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GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
Product Assessment Report
GOIBI XTREME FORTE REPELENTE INSECTOS SPRAY May 2016 Updated document (October 2019)
Amended sections: 1.4; 1.5.1; 1.5.2; 1.5.4; 1.6.1; 2.2.1; 2.4, 2.5; 2.6.; 2.7.1.2; 2.7.2; 2.7.2.2; 2.7.3;
2.7.3.2; 2.8; 2.9; 3; Annex 1 sections 1.1;1.2; 2.1; 3; 4.1; 5.1; 5.4.; Annex 5; Annex 6; Annex 7
[NA-ADC-BC-NY050925 99]
[NA-MIC-BC-VK050926-17]
Internal registration/file no:
Authorisation/Registration no: ES/APP(NA)-2016-19-00365
Granting date/entry into force
of authorisation/ registration:
Expiry date of authorisation/
registration:
31 July 2022
Active ingredient: DEET
Product type: 19
Biocidal product assessment report related to product authorisation under Directive 98/8/EC
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
Contents
1 General information about the product application ................... 1
1.1 Applicant ............................................................................................................................ 1 1.1.1 Person authorised for communication on behalf of the applicant ........................ 1
1.2 Current authorisation holder .............................................................................................. 1
1.3 Proposed authorisation holder .......................................................................................... 1
1.4 Information about the product application ......................................................................... 2
1.5 Information about the biocidal product .............................................................................. 2 1.5.1 General information .............................................................................................. 2 1.5.2 Information on the intended use(s)....................................................................... 3 1.5.3 Information on active substance(s) ...................................................................... 3 1.5.4 Information on the substance(s) of concern ......................................................... 4
1.6 Documentation .................................................................................................................. 4 1.6.1 Data submitted in relation to product application ................................................. 4 1.6.2 Access to documentation ..................................................................................... 4
2 Summary of the product assessment .......................................... 5
2.1 Identity related issues ........................................................................................................ 5
2.2 Classification, labelling and packaging ............................................................................. 5 2.2.1 Harmonised classification and labelling of the biocidal product ........................... 5 2.2.2 Packaging of the biocidal product ........................................................................ 6
2.3 Physico/chemical properties and analytical methods ....................................................... 6 2.3.1 Physico-chemical properties ................................................................................ 6 2.3.2 Analytical methods ............................................................................................... 7
2.4 Risk assessment for Physico-chemical properties ............................................................ 7
2.5 Effectiveness against target organisms ............................................................................ 7 2.5.1 Dose / mode of action / known limitations / resistance ........................................ 7
2.6 Exposure assessment ..................................................................................................... 11 2.6.1 Description of the intended use(s) ...................................................................... 11 2.6.2 Assessment of exposure to humans and the environment ................................ 11
2.7 Risk assessment for human health ................................................................................. 12 2.7.1 Hazard potential ................................................................................................. 12 2.7.2 Exposure ............................................................................................................ 15 2.7.3 Risk Characterisation ......................................................................................... 21
2.8 Risk assessment for the environment ............................................................................. 24
2.9 Measures to protect man, animals and the environment ................................................ 43
3 Proposal for decision .................................................................. 43
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
1 General information about the product
application
1.1 Applicant
Company Name: Laboratorios Cinfa, S.A.
Address: Olaz-Chipi, nº 10
City: Huarte – Pamplona
Postal Code: 31620
Country: Spain
Telephone: +34 948 335005
Fax: +34 948 333774
E-mail address: [email protected]
1.1.1 Person authorised for communication on behalf of the applicant
Name: Mrs. Ana Berta Arrieta Azpilicueta
Function: Regulatory Affairs Manager
Address: Olaz-Chipi, nº 10
City: Huarte – Pamplona
Postal Code: 31620
Country: Spain
Telephone: +34 948 335005
Fax: +34 948 333774
E-mail address: [email protected]
1.2 Current authorisation holder1
Company Name: Laboratorios Cinfa, S.A.
Address: Olaz-Chipi, nº 10
City: Huarte – Pamplona
Postal Code: 31620
Country: Spain
Telephone: +34 948 335005
Fax: +34 948 333774
E-mail address: [email protected]
Letter of appointment
for the applicant to
represent the
authorisation holder
provided (yes/no):
1.3 Proposed authorisation holder
Company Name: Laboratorios Cinfa, S.A.
Address: Olaz-Chipi, nº 10
City: Huarte – Pamplona
Postal Code: 31620
1 Applies only to existing authorisations
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
Country: Spain
Telephone: +34 948 335005
Fax: +34 948 333774
E-mail address: [email protected]
Letter of appointment
for the applicant to
represent the
authorisation holder
provided (yes/no):
1.4 Information about the product application
Application received: 30/07/2012
Application reported
complete:
-
Type of application: authorisation
Further information: ES has GOIBI XTREME FORTE REPELENTE DE INSECTOS
SPRAY currently authorised under national legislation for use as
repellent (PT19). The current application is for PT19 use and that
will be assessed and authorised under 98/8/EC.
1.5 Information about the biocidal product
1.5.1 General information
Trade name: GOIBI XTREME FORTE REPELENTE DE
INSECTOS SPRAY
Manufacturer’s development code
number(s), if appropriate:
-
Product type: 19
Composition of the product (identity and
content of active substance(s) and
substances of concern; full composition
see confidential annex):
45 % DEET (N,N-diethyl-m-toluamide)
Formulation type: Spray
Ready to use product (yes/no): Yes
Is the product the very same (identity
and content) to another product already
authorised under the regime of directive
98/8/EC (yes/no);
If yes: authorisation/registration no. and
product name:
or
Has the product the same identity and
composition like the product evaluated
in connection with the approval for
listing of active substance(s) on to Annex
I to directive 98/8/EC (yes/no):
No
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
1.5.2 Information on the intended use(s)
Overall use pattern (manner and area of
use):
Apply only on the uncovered skin. Do not
apply on clothing.
Apply the product sparingly and carefully;
divide the product evenly over the skin.
The product can be used only once per day on
adults and children over 2 years of age.
No use in children under 2 years old.
Target organisms: Mosquitoes: Anopheles spp. and Aedes spp.
Ticks: Ixodes ricinus
Category of users: Non-professional user (general public)
Directions for use including minimum
and maximum application rates,
application rates per time unit (e.g.
number of treatments per day), typical
size of application area:
Potential for release into the
environment (yes/no):
Potential for contamination of
food/feedingstuff (yes/no)
No
Proposed Label: See the authorisation
Use Restrictions: See the authorisation
1.5.3 Information on active substance(s)2
Active substance chemical name: DEET (N,N-diethyl-m-toluamide)
CAS No: 134-62-3
EC No: 205-149-7
Purity (minimum, g/kg or g/l): 970 g/kg
Inclusion directive: Directive 2010/51/EU
Date of inclusion: 1 August 2012
Is the active substance equivalent to the
active substance listed in Annex I to
98/8/EC (yes/no):
Yes
Manufacturer of active substance(s) used
in the biocidal product:
Vertellus Performance Materials Inc. (formerly
Morflex, Inc.)
Company Name: Vertellus Performance Materials Inc.
Address: 2110 High Point Road
City: Greensboro (NC)
Postal Code: NC 27403
Country: USA
Telephone: 336 292 1781
Fax: 336 854 4058
E-mail address: www.vertellus.com
2 Please insert additional columns as necessary
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
1.5.4 Information on the substance(s) of concern3
Substance chemical name Ethanol
CAS No: 64-17-5
EC No : 200-578-6
Purity (minimum, g/kg or g/l): -
Typical concentration (minimum
and maximum, g/kg, or g/l):
Please, see information in the confidential annex of this
document about the composition of the biocidal product
Relevant
toxicological/ecotoxicological
information:
-
Original ingredient (trade name): -
Based on the legal classification as provided in the safety data sheet submitted by the applicant and
the concentration in the biocidal product above 0.1 %, the component listed above (ethanol) was
identified as substance of concern according to the Biocidal Products Directive 98/8/EC (BPD) and
the current drafts on guidance for SoC. Ethanol is classified with the hazard statement H225.
In addition, ethanol was notified as active substance for the product types 1, 2 and 4 according to the
biocides review programme although in this product is a solvent.
On the other hand, C&L inventory database of ECHA contains classification and labelling
information on notified and registered substances received from manufacturers and importers.
Ethanol is included by some notifiers with the hazard statement H319 (Causes serious eye irritation).
Anyway, since the prevention of the risk of eye irritation is addressed in the labelling of the product
and taken into account that exposure by inhalation is considered negligible, the potential risks
towards ethanol during application of GOIBI XTREME FORTE REPELENTE DE INSECTOS
SPRAY are sufficiently controlled by classification and labelling of the product. For this reason a
quantitative risk characterization is not required for this substance of concern.
1.6 Documentation
1.6.1 Data submitted in relation to product application
The applicant has not sent new data about the active substance regarding physico/chemical
properties, analytical methods and human health in order to support the product authorisation.
According to the applicant, the formulation of “GOIBI XTREME FORTE REPELENTE DE
INSECTOS SPRAY” has no impact on the route or rate of degradation of the active substance
DEET in the environment. So, it was concluded that no additional studies involving the formulated
product are required. There is no substance of concern in the formulated product except the active
ingredient DEET: the biocidal product contains various compounds different from the active
substance (45% DEET) classifying as dangerous for the environment (denatonium benzoate, D-
limonene, and citral), but it should not be considered of concern due to the low percentage in which
it is present in the biocidal product. Therefore environmental effects of the product can be
extrapolated from the environmental effect studies on DEET.
The biocidal product is a spray to dermal use ready to use.
1.6.2 Access to documentation
The applicant has submitted the following letter of access:
3 Please insert additional columns as necessary
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
- a letter of access from Vertellus Performance Materials Inc. (formerly Morflex, Inc.) to all
the documents about the active substance DEET associated to the Annex I listing. Vertellus
has access to the data used and submitted for the inclusion of DEET into Annex I of
Directive 98/8/EC.
Vertellus Performance Materials Inc. (formerly Morflex, Inc.) was considered as a new
source and the technical equivalence was carried out by SE. The RMS considered that the
DEET material manufactured by the different sources to be equivalent and it was hence
acceptable for the manufacturers to join one task-force.
All substances data sheets are included in the dossier.
2 Summary of the product assessment
2.1 Identity related issues
The active substance DEET (N, N-diethyl-meta-toluamide) was included in the Annex I of Directive
98/8/EC (Commission Directive 2010/51/EC of 11 August 2010).
The formulation includes several components. The biocidal product contains a substance of concern
according to the Technical Notes for Guidance on data requirements (please, see section 1.5.4).
Information on the full composition of the product and assessment are detailed in additional
confidential annex of this document.
According to article 19(9) of Regulation (EU) No 528/2012 of the European Parliament and of the
Council of 22 May 2012 concerning the making available on the market and use of biocidal
products, the non-active substances of the biocidal product are included pursuant to Regulation (EC)
No 1223/2009 (Commission Decision of 9 February 2006 amending Decision 96/335/EC
establishing an inventory and a common nomenclature of ingredients employed in cosmetic
products).
2.2 Classification, labelling and packaging
2.2.1 Harmonised classification and labelling of the biocidal product
According to Regulation 1272/2008 (Until 1 June 2015, mixtures shall be classified, labelled and
packaged in accordance with Directive 1999/45/EC):
GHS Pictograms
Signal Word Danger
Classification Hazard class and
category:
Hazard statement
Flam. Liq. 2
Eye irrit. 2
Aquatic Chronic 3
H225: Highly flammable liquid and vapour
H319: Causes serious eye irritation
H412: Harmful to aquatic life with long lasting effects.
EUH 208: “Contains D-Limonene and Citral. May
produce an allergic reaction”.
General
precautionary
statement
P102: Keep out of reach of children
P103: Read label before use
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
Prevention
precautionary
statement
P210: Keep away from heat/sparks/open flames/hot surfaces. No smoking
P233: Keep container tightly closed
P264: Wash … thoroughly after handling
P273: Avoid release to the environment.
Response
precautionary
statements
P370+P378: In case of fire: use....for extinction
Storage
precautionary
statements
P403+P235: Store in a well-ventilated place. Keep cool
Disposal
precautionary
statements
P501: Dispose of content and / or its container as hazardous waste according
to the regulations in force
2.2.2 Packaging of the biocidal product
The biocidal product is packaged in a PP container of 75ml net with a PE cap diffuser (0.14ml)
The packaging of the product placed on the market has to be limited to a maximum size of 200ml.
The packaging of the biocidal product shall be fitted with a tactile warning of danger.
2.3 Physico/chemical properties and analytical methods
2.3.1 Physico-chemical properties
Regarding the active substance DEET the table has not been filled in because the letters of access
have been submitted.
Regarding the biocidal product, these are the physico-chemical properties:
Table 1: Physico-chemical properties of the biocidal product:
Method Purity/Specification Results Reference
Physical state and nature Visual 45% Liquid B.3.1.1
Colour Yellowish B.3.1.2
Odour Characteristic B.3.1.3
Explosive properties None of the components are
classified as explosive
B.3.2
Oxidizing properties None of the components are
classified as oxidant
B.3.3
Flash point EC method A.9 19.5ºC B.3.4
Autoflammability EC method
A.12
The product does not
produce gas in contact with
water
B.3.4
Auto-ignition
Temperature
EC method
A.15
394ºC B.3.4
Acidity / Alkalinity CIPAC method
MT 75.3
pH:8
(0.15mL NaOH 0.1N)
B.3.5
Relative density / bulk
density
0.898 g/ml B.3.6
Storage stability –
stability and shelf life
Stable for 3 months at
25ºC2ºC and 60%±5%
H.R.
B.3.7
Effects of temperature Any change is observed in
the product during the
storage at next conditions:
25ºC/60%HR,
B.3.7
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
Method Purity/Specification Results Reference
40ºC/75%HR and 4ºC-8ºC
for 3 months
Effects of light -
Reactivity towards
container material
None reactivity was
observed towards container
material
B.3.7
Technical characteristics
in dependence of the
formulation type
The product is ready to use B.3.8
Compatibility with other
products
The product is ready to use B.3.9
Surface tension EC method A.5 28.9 mN/m at 20ºC B.3.10
Viscosity n.a
Particle size distribution n.a
n.a = not available
2.3.2 Analytical methods
Principle of method
Technical active substance as manufactured: GC-FID y GC-MS
Impurities in technical active substance: GC-FID y GC-MS
Active substance in the formulation: HPLC - UV at 275 nm
2.4 Risk assessment for Physico-chemical properties
The active substance DEET is not highly flammable, auto-flammable, explosive or oxidizing and
should thus not be classified based on its physic-chemical properties.
The biocidal product GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY contains 45
%w/w DEET and given the nature of the formulation it is not considered explosive, oxidizing or
auto- flammable.
The first authorisation was conditioned to the submission of a new long term stability test. Applicant
submitted in June 2018 a new test but the information included is related to the packaging and no to
the variation in the concentration of the active substance. In addition, a long term stability test was
submitted by other biocidal product in the first authorisation (GOIBI ANTIMOSQUITOS FAMILIA
SPRAY) which complied with the variation of the active substance concentration. For this, ES CA
thinks that a new test should be submitted in the renewal of the product and the shelf life will be 3
months.
2.5 Effectiveness against target organisms
2.5.1 Dose / mode of action / known limitations / resistance
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY is an insect repellent (PT19)
based on 45% DEET.
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY is used to repel ticks and
mosquitoes . This product is an insect repellent for outdoor use, or indoor use in well ventilated
areas, that should be applied to the skin of exposed body parts with the purpose to protect the
uncovered skin of humans against biting ticks and mosquitoes.
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
DEET (N,N-Diethyl-m-toluamide) repels mosquitoes without time delay. The mechanism of action
of the active ingredient is not revealed yet; however, its effectiveness is determined experimentally.
Protection time provided by DEET is proportional to logarithmic dose concentrations, with
increased duration of efficacy at higher concentrations; however, increase of duration of efficacy
tends to plateau at a concentration of approximately 50% active substance.
New laboratory studies have been provided with the mosquitoes Anopheles gambiae and Aedes
albopictus and the tick Ixodes ricinus. The results are summarized in Table below.
Table: The following table shows the efficacy of the active substance from its use in the
biocidal product - GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY Test
substance
Test organism(s) Test system/concentrations
applied/exposure time
Test results:
effects, mode
of action,
resistance*
Reference
GOIBI
ANTIMOSQ
UITOS
XTREME
SPRAY
Anopheles
gambiae
Arm-in-test cage: The study was
repeated 5 times in the volunteer's
forearm treated and untreated.
Applying a product on the forearm
repellent with an amount of 1.00
grams per 600 cm2. Test cages
containing 50 female adults of
Anopheles Gambiae, 6 days old and
show a trophic activity was tested.
Aspire females of breeding cages
and then are introduced into test
cages 30 minutes before each
repetition. Before each repetition of
the study, the activity of mosquito
bites on the forearm was assessed
untreated. The arm of the volunteer
without treatment was introduced
into the box and after 1 minute are
beginning to assess the number of
attempts to bite, considered valid if
there were at least 10 attempts to
nibble in 30 seconds The trial began
five minutes after treating the
forearm voluntary testing and
finished 8 hours after treatment.
During that time, the test was
performed at intervals of one hour.
The exposure time of the forearms
of volunteers was 3 minutes per
interval. The number of pits and the
number of landings is recorded. The
test ended when the volunteer had
two bite attempts within a test
interval or within two subsequent
testing intervals.
Test method: Product
performances test guidelines
according to the EPA guideline
OPPTS 810.3700 and
WHO7HTM/NTD/WHOPES/2009.
4
The Collected
data show
Long Product
Efficacy tests
providing
complete
protection
against
Anopheles
gambiae 5.8
hours
s-2013-02018-
2 INC
GOIBI
ANTIMOSQ
UITOS
XTREME
SPRAY
Aedes albopictus Arm-in-test cage: Each test consists
of 5 repetitions with different
persons of the two sexes in a ratio
of 2:3. The study was repeated 5
times in the volunteer's forearm
treated and untreated. Applying a
The average of
the protection
percentage
stay 100% up
to 8 hours
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
product on the forearm repellent
with an amount of 1.15 gr/600 cm2.
Test cages containing 50 female
adults of Aedes albopictus 5 days
old and show a trophic activity was
tested. Aspire females of breeding
cages and then are introduced into
test cages 30 minutes before each
repetition. Before each repetition of
the study, the activity of mosquito
bites on the forearm was assessed
untreated. The arm of the volunteer
without treatment was introduced
into the box and after 1 minute are
beginning to assess the number of
attempts to bite, considered valid if
there were at least 10 attempts to
nibble in 30 seconds The trial began
five minutes after treating the
forearm voluntary testing and
finished 8 hours after treatment.
During that time, the test was
performed at intervals of 3 minutes
each 30 minutes during 8 hours.
The number of pits and the number
of landings is recorded. . Each
repetition is considered finished
when the protection percentage
drops under 95%. The parameter
evaluating is PROBING, this them
indicates a mosquito´s attempt to
bite. A probing is counted when the
insect has alighted or “landed” on
one´s arm, when it assumes the
typical posture and “tastes” the skin
with its mouth apparatus. As
Tiger’s mosquitos is very
aggressive specie which bite as
soon is landed, for this species
probing and landing can be
assumed as same meaning. The
protection percentage of the test
formulation is calculated according
to the following formula: %
PROT= 100 – (Σ probing on the
treated arm x 100 : Σ probing on the
untreated arm).
Test method: Product
performances test guidelines
according to the EPA guideline
OPPTS 810.3700 and
WHO7HTM/NTD/WHOPES/2009.
4, TNsG CA- DEC 12 – Doc.6.2.a
GOIBI
ANTIMOSQ
UITOS
XTREME
SPRAY
Ixodes ricinus The forearm of each volunteer was
treated with repellent product,
approx. 1.15 gr / 600 cm2, from the
elbow to the wrist, except a round
area of approximately 16 cm2
which is allowed untreated. To stop
monitoring the untreated area is
covered with a plastic cover
secured with a rubber band until the
product has evaporated. The
The average of
the protection
percentage
doesn´t goes
below 95% for
8 hour.
None of the
ticks crossed
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
amount of product has been applied
is evaluated by measuring the
weight of the product packages
before and after application. In
order to avoid contamination of the
forearm control voluntary gets a
mono-use sleeve. In the midst of
experiments, based on the control
arm is left forearm while the treaty
is uncovered in order not to hinder
the natural process of evaporation
of repellent product. The forearm of
volunteer stays in a vertical position
with the palm of the hand and
fingers on the table. Ticks are
placed one by one in the untreated
area. Ticks that move the treated
area for at least 60 seconds are
considered as repelled. Ticks do not
move to the treated area, which
they return to the untreated area
within 60 seconds, or those who are
dropped from the skin are
considered to be repelled. All ticks
both repelled as renewed repelled
and collected in each experiment:
Each tick is used only for one test.
The test provides the evaluation of
5 ticks after 30 minutes from when
the product is applied and
subsequently every hour. Each test
consists of 5 repetitions with
different people. Time protection is
considered as the time until the first
intersection confirmed within a trial
period of 60 minutes is observed. A
cross is defined as a movement of
tick’s untreated skin to the treated
area and quantified with a stay in
the treated area for 60 seconds. A
cross is a cross confirmed by a
second crossing another tick
observations within 30 minutes.
The test is terminated if 5 ticks
within a probationary period are not
repelled by 1 hr. Otherwise; the test
is repeated until a total of eight
hours.
Test method: USA guidelines and
EPA guidelines for the evaluation
of skin repellent products for
human use in a open environment,
OPPTS 810.3700, EPA draft
guidelines for the evaluation of
insects skin repellent products for
use on human, Sept, 23, 2008
the second
mark on the
treated skin
during 4
hours,
resulting in a
mean PT of at
least 4 hours.
These tests show the efficacy of GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
against mosquitoes in simulated-use tests (arm-in-cage) and against ticks in a laboratory test. The
results of the arm-in-cage studies show that GOIBI XTREME FORTE REPELENTE DE
INSECTOS SPRAY repels Anopheles spp. and Aedes spp. for on average 5 and 8 hours respectively.
The laboratory test with Ixodes ricinus shows that ticks are repelled for at least 8 hours.
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
2.5.1.1 Dose
The active substance is incorporated into a ready to use spray at a concentration of 45% and is used
by the general public (non-professional users). The product is used as an application on the skin and
exposed areas must be used every 8 hours. The exposure time in areas with mosquitoes, it is
expected that the product is applied only once daily. If the exposure time in areas with mosquitoes or
ticks is greater than 8 hours, the product should be reapplied. Nevertheless, according to the
exposure assessment only once per day can be applied.
2.5.1.2 Mode of action
DEET repels biting and sucking insects without time delay. The mechanism of action of the active
ingredients in insect repellents is not revealed yet; however, their effectiveness is determined
experimentally.
2.5.1.3 Known limitations
Product must be reapplied after swimming, showering or when the efficiency decreases.
Nevertheless, according to the exposure assessment only once per day can be applied.
2.5.1.4 Resistance
There is no known instance of target insects developing resistance to DEET. It is unlikely that
resistance will occur for DEET, since there is only low selection pressure because the insects that are
repelled do not die, and there are many other food sources available for these insects. Therefore, it is
considered unnecessary to take actions to prevent development of resistance by target organisms.
2.6 Exposure assessment
2.6.1 Description of the intended use(s)
The biocidal product GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY is a ready to
use spray for non-professional / general public use, which contains 45% DEET (N,N-diethyl-m-
toluamide). The biocidal product is applied 1 time per day by spray on the body areas to be
protected.
MG/PT Field of intended use Likely concentration at
which a.s. will be used
MG03/PT19 Non-professional users (consumers), direct
application onto the skin.
45%
2.6.2 Assessment of exposure to humans and the environment
Regarding humans health, no new exposure studies have been submitted.
No new studies have been provided concerning environmental exposure. According to the applicant
the product contains only one active substance (DEET) at 45%. The product contains other
substances of concern for the environment but at a low concentration and does not affect the
product’s classification. Thus, the environmental effects of the product can be extrapolated from the
environmental effect studies on DEET.
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
The environmental risk assessment has been performed by the ES CA since no evaluation has been
performed by the applicant.
2.7 Risk assessment for human health
2.7.1 Hazard potential
2.7.1.1 Toxicology of the active substance
The toxicology of the active substance DEET was examined extensively according to standard
requirements. The results of this toxicological assessment can be found in the CAR of the active
substance. The threshold limits and labelling regarding human health risks listed in Annex 4
“Toxicology and metabolism” must be taken into consideration.
2.7.1.2 Toxicology of the substance(s) of concern
Substance chemical name Ethanol
CAS No: 64-17-5
EC No : 200-578-6
Purity (minimum, g/kg or g/l): -
Typical concentration (minimum
and maximum, g/kg, or g/l):
Please, see information in the confidential annex of this
document about the composition of the biocidal product
Relevant
toxicological/ecotoxicological
information:
-
Original ingredient (trade name): -
Based on the legal classification as provided in the safety data sheet submitted by the applicant and
the concentration in the biocidal product above 0.1 %, the component listed above (ethanol) was
identified as substance of concern according to the Biocidal Products Directive 98/8/EC (BPD) and
the current drafts on guidance for SoC. Ethanol is classified with the hazard statement H225.
In addition, ethanol was notified as active substance for the product types 1, 2 and 4 according to the
biocides review programme although in this product is a solvent.
On the other hand, C&L inventory database of ECHA contains classification and labelling
information on notified and registered substances received from manufacturers and importers.
Ethanol is included by some notifiers with the hazard statement H319 (Causes serious eye irritation).
Anyway, since the prevention of the risk of eye irritation is addressed in the labelling of the product
and taken into account that exposure by inhalation is considered negligible, the potential risks
towards ethanol during application of GOIBI XTREME FORTE REPELENTE DE INSECTOS
SPRAY are sufficiently controlled by classification and labelling of the product. For this reason a
quantitative risk characterization is not required for this substance of concern.
2.7.1.3 Toxicology of the biocidal product
The toxicology of the biocidal product GOIBI XTREME FORTE REPELENTE DE INSECTOS
SPRAY was examined appropriately according to standard requirements. The product was not a
dummy product in the EU- review program for inclusion of the active substance. Justification for
non-submission of data has been submitted for acute oral, dermal and inhalation toxicity. In
addition, the information derived from existing data on the active substance DEET and co-
formulants has been used, in order to minimise animal testing.
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
NA-MIC was submitted in April 2019 in order to change the fragrance. The concentration of the
fragrance is the same but the components of the fragrance have some small differences which only
affect to the sensitisation (EUH208). This CA thinks that the rest of the evaluation regarding
toxicological effects remains valid.
Dermal Absorption:
A study was submitted for the biocidal product GOIBI XTREME FORTE REPELENTE DE
INSECTOS SPRAY to assess its potential to permeate human skin. The in-vitro dermal absorption
study was carried out in accordance with the OECD 428 Guide “Dermal delivery and Percutaneous
Absorption: In vitro method, adopted 13 April 2004”. The final formulation (“in-use” concentration)
of the biocidal product was tested. Dermal absorption was expressed as a percentage of the total
amount recovered. Skin was treated for 8h with the test item followed by further sampling up to 24h.
Most of the applied dose (in mean more than 86%) was found remaining on the skin surface and was
detected in the skin wash. In the total absorption the amount of test item of strips ≥3, skin, gauze,
receptor fluid and chamber wash RF is included. The amount of test item in strip 1 and 2 only was
excluded from absorption, since less than 75% of the absorption occurs within half the duration of
the study according to EFSA guidance on dermal absorption. The mean total absorption was found
to be 11%, values for the single replicates ranging from 8% to 15%. Please, see table below:
Sample Mean (%) SD (%)
Skin wash 8h 84 5
Skin wash 24h 2 2
Chamber wash 0.8 0.9
Strips 1+2 2 2
Strips ≥3 1 1
Skin 0.9 0.3
Receptor Fluid 8 2
Gauze 0.6 0.3
Chamber wash RF 0.4 0.2
Total absorption 11 3
Recovery 87 3
Absorption after 12h 58 6
Absorption after 12h >75%* no
* when absorption after 12h is >75%, strips ≥3 can be excluded from the total absorption
Acute toxicity:
No studies were submitted for the biocidal product. Justification for non-submission of data has been
submitted for acute oral, dermal and inhalation toxicity. The Spanish CA accepts the applicant's
justification and the data package.
The active substance DEET is classified as dangerous substances by oral acute toxicity and it exists
in concentration that contributes to the classification of the product with the symbol Xn and the risk
phrase R22 according to the criteria of Directive 1999/45/EC. On the other hand, according to CLP
Regulation, where the mixture itself has not been tested to determine its acute toxicity, but there are
sufficient data on the individual ingredients and similar tested mixtures to adequately characterise
the hazards of the mixture, these data shall be used in accordance with the bridging rules. The acute
toxicity estimate (ATE) of the mixture is determined by calculation from the ATE values for all
relevant ingredients according to the following formula for oral, dermal or inhalation toxicity:
where:
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
Ci = concentration of ingredient i (% w/w or % v/v)
i = the individual ingredient from 1 to n
n = the number of ingredients
ATEi = Acute Toxicity Estimate of ingredient i
Considering the LD50 (oral) value and concentration of DEET, the ATEmix is 4166 mg/kg and the
biocidal product is not classified by oral acute toxicity according to CLP Regulation, table 3.1.1.
In addition, the biocidal product GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
does not contain any dangerous substance classified by dermal and inhalation acute toxicity. The
study of acute inhalation toxicity was waived because the inhalation route is excluded due to the use
outdoor, and because the use indoor only takes place in summer, in situations where there is a high
ventilation rate. Furthermore, as reported in the CAR of DEET, the active substance is a low volatile
compound that has not and high distribution in air compartment.
Irritation and corrosivity:
Skin irritation
The active susbtance was considered to be skin irritant. In addition, there is a study performed with
the biocidal product. Considering the study, the biocidal product is not classified as irritant to skin.
A summary of the study is given below:
Species Method
Average score
(24, 48, 72h) Result Remark Reference
Erythema Oedema
Rabbit OECD 404
GLP
0
(0-0-0)
0
(0-0-0)
Completely
reversible Not irritating B6.2(1)
In adittion, a non-clinical local tolerance test was performed according to the Note for Guidance on
non-clinical local tolerance testing of Medicinal Products, CPMP/SWP/2145/00. The results showed
a good tolerance when the biocidal product was applied to the skin one time a dailyduring 14 days.
A summary of the study is given below:
Week Daily Index of erythema and oedema weekly
index
Maximum
daily index
Final Daily
index
(24h after
last
application)
Final Index
(reversibility)
1
Day
2
Day
3
Day
4
Day
5
Day
6
Day
7
Day
8 0.40
0.83 0.00 0.00 0.33 0.83 0.67 0.67 0.33 0.00 0.00
2
Day
9
Day
10
Day
11
Day
12
Day
13
Day
14
Day
15 0.00
0.00 0.00 0.00 0.00 0.00 0.00 0.00
Eye irritation
No study was submitted. The active substance DEET was classified in the CAR as irritant to eyes
according to Directive 1999/45/EC and according to CLP Regulation, Annex VI. Considering the
concentration of the active substance, the biocidal product GOIBI XTREME FORTE REPELENTE
DE INSECTOS SPRAY is classified as R36 Irritant to eyes and assigned the symbol Xi according to
Directive 1999/45/EC (the concentration is higher than 20%) and according to CLP Regulation (the
concentration is higher than 10%); it is classified as Eye irrit. 2 and the hazard statement H319.
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
Taking into account the proposal of some notifiers about irritating properties to eyes of ethanol, the
classification of labelling of the biocidal product will be the same with the hazard statement H319.
Sensitization:
A study was conducted to assess the skin sensitization potential with the biocidal product in mice.
The method was carried out according to the guidelines of OECD N° 429 (skin sensitisation: Local
lymph node assay, LLNA method). The purpose of this local lymph node assay was to identify the
contact allergenic potential of GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
when administered to the dorsum of both ear lobes of mice at concentrations of 25%, 50% (each
diluted with acetone/olive oil 4:1 v/v) and 100%. On basis of the results, at the daily clinical
observation the animals did not show any visible clinical symptoms and no case of mortality was
observed. None of the three tested concentrations of the test item reached the simulation index of 3.
- The stimulation index at a concentration of 25% was 1.2.
- The stimulation index at a concentration of 25% was 2.0.
- The stimulation index at a concentration of 25% was 1.4.
Consequently, according to OECD 429 the biocidal product GOIBI XTREME FORTE
REPELENTE DE INSECTOS SPRAY is expected to have no sensitising properties and therefore
should not be regarded as a dermal sensitiser.
Nevertheless, some substances included in the biocidal product could produce an allergic reaction.
These substances (fragrances) are not present in the biocidal product at sufficient concentration(s) to
trigger a human health classification but, according to the Regulation 286/2011 of 10 March 2011
amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No
1272/2008 of the European Parliament and of the Council on classification, labelling and packaging
of substances and mixtures (section 2.8, Annex II), the label on the packaging of mixtures not
classified as sensitising but containing at least one substance classified as sensitising and present in a
concentration equal to or greater than that specified in Table 3.4.6 of Annex I, of this regulation,
shall bear the statement:
EUH208 — “Contains (name of sensitising substance). May produce an allergic reaction”.
NA-MIC was submitted in April 2019 in order to change the fragrance. The substances included in
the fragrance have been evaluated because some of them could produce an allergic reaction. In this
sense, they are not present in the biocidal product at sufficient concentration(s) to trigger a human
health classification but, according to CLP regulation, the statement EUH208 should be included
again with the substances: d-limonene and citral.
For this reason, the label of GOIBI XTREME FORTE REPELENTE DE INSECTOS TOALLITAS
will include the statement: EUH 208: “Contains D- Limonene and Citral. May produce an allergic
reaction” according to CLP Regulation.
2.7.2 Exposure
The exposure of the biocidal products containing DEET has been re-assessed in line with the
Commission implementing Decision (EU) 2018/1477 of 2 October 2018 on the terms and conditions
of the authorisations of biocidal products containing ethyl butylacetylaminopropionate applicable to
DEET.
There is a discrepancy between the application rate obtained from the efficacy studies and the
application rate used in the exposure assessment. The application rate proven efficacious should be
considered to assess the exposure (Article 19(1)(b)(i) of Regulation (EU) No 528/2012), even
though it is acknowledged that it may lead to an unacceptable risk for human health with regard to a
number of the intended uses (Article 19(1)(b)(iii)).
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
Until a consensus on how to generate efficacy for insect repellents data is reached, the human health
risk assessment should contemplate the efficacy doses. Therefore the RMS has re-calculated the
exposure with the dose that has proven to be efficient. Hence, the dose proven efficacious (1.15
g/600 cm2) has been considered in line with the Commission implementing Decision (EU)
2018/1477.
The product GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY is a ready-to-use
spray containing DEET at a concentration of 45 %. The product is packed a plastic bottle of 75 ml
net with cap dispenser of 0.14 ml (see section 2.2.2). It is applied onto the body areas to be
protected. The biocidal product will be used by non-professional users. Primary exposure is
expected in adults and children over 2 years of age; the use of DEET products is not allowed for
children of less than 2 years of age (DEET CAR).
The main paths of human exposure towards this active substance from its use in biocidal product
are:
Table 2.7.2- 1 Summary of main paths of human exposure
Exposure route Industrial use Professional use General public Through the
environment
Inhalation NA NA Insignificant Insignificant
Dermal NA NA Main route Insignificant
Oral NA NA Significant Insignificant
The product is intended to be used per dermal route. The exposure assessment is based performed
assuming a frequency of one time per day, as described by the applicant. Dermal route is the main
path of exposure.
Exposure by inhalation is considered to be negligible due to the large particle size. Additionally,
with respect to insect repellents, in the section 5.2 of the "Technical Notes for Guidance - Human
Exposure to Biocidal Products - Guidance on Exposure Estimation" (European Commission, 2002,
part 2), states: "The inhalation route is excluded due to the use outdoors, and because use indoors
takes place in the summer in situations where there is a high ventilation rate. On these grounds, the
inhalation exposure to aerosol sprays is also considered to be negligible". This extreme was admitted
for the assessment of the active substance (DEET CAR) the inhalation exposure was not assessed.
However, since the inhalation exposure cannot be completely ruled out a recommendation for
adequate ventilation has been included on the product label.
Oral exposure by hand-to-mouth transfer is not considered a significant route of exposure since due
to its smell and taste, the DEET acts as a self-deterrent. More importantly, all the products of this
family contain an ingredient that acts as a strong deterrent for ingestion (Bitrex). However, it should
be noticed that Bitrex may not be effective in preventing ingestion in all age groups, in particular
children < 12 years old (Technical Meeting Agreement). On this basis, the oral route is considered
possible and therefore the calculations for hand-to-mouth exposure have been included in the worst
case exposure calculations.
2.7.2.1 Exposure of professional users
The product is not intended for professional use.
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
2.7.2.2 Exposure of non-professional users and the general public
The exposure calculations are based on the Recommendation 11 Ad hoc Working Group Human
Exposure “proposal for harmonizing the assessment of human exposure to repellents (PT19)” as
well as on Biocides Human Health Exposure Methodology (ECHA, 2015).
The assessment of the systemic effects has been carried out using the UK proforma approach which
is based on the application rates supported by efficacy data. The Proforma method defines a
maximun skin area that can be treated safely using a reverse referece scenario. The risk calculations
are based on the toxicologically determined AEL for the active substance. Consequently, the
potential exposure of the biocidal product is calculated by determining the maximum dose that can
be applied onto a person without exceeding the AEL.
The daily exposure has been calculated for adults, children from 12 to < 18 years of age; children
from 6 to < 12 years of age; and children from 2 to < 6 years of age. It is agreed that the
Recommendation 14 of the Ad hoc working group human exposure does not cover the ages from 12
to 18 years old. In order to simplify the re-assessment, it is assumed that the exposure of adults
covers the population of children from 12 to < 18 years of age in a worst-case basis.
The default values fo body weight and surface area described at the Recommendation 14 of Ad hoc
working group on human exposure are used for exposure assessment. The biocidal product is
applied directly onto the body areas to be protected. For adults and children, the head, arms, legs,
trunk and feet could be treated according to US EPA Child-Specific Exposure Factors Handbook,
2002. In addition, since the product can be used in people wearing swimming suits and therefore
with the trunk exposed, the trunk has been included as a possible body part to spray on.
The parameters considered to calculate are:
Parameters Value
DEET AELrepeated (acceptable exposure limit a.s.) 8.2 mg a.s./kg bw/day
Number of applications One per day (applicant)
Concentration of DEET in the product (AS) 45 %
Dermal absorption for DEET (DA) 11 %
Oral absorption for DEET (AA) 100 % (worst-case approach)
Amount of BP in a single spray spot1 140 ml
Efficacy (g DEET/cm2 skin) 1,15 g/600 cm
2 (0.0019 g/cm
2)
Amount of the product applied that expected to be ingested 2
Adults 4 % applied dose (product on fingers)
Children 8 % applied dose (product on hands)
Transfer coefficient3 100 %
Area of skin that can be treated (head, trunk, arms, legs, trunk and feet) 4
Adults/ Child > 12 years 16600 cm2
Child 6 to < 12 years 9200 cm2
Child 2 to < 6 years 6800 cm2
Body weight 5
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
Parameters Value
Adults/ Child > 12 years 60 Kg
Child 6 to < 12 years 23.9 Kg
Child 2 to < 6 years 15.6 Kg 1 75 ml net with cap diffuser of 0,14 ml (see section 2.2.2) 2 Amount of product ingested (mg/Kg/day), assuming that a % of the amount deposited is available orally with a transfer coefficient of 100% (Recommendation 11 Ad hoc WGHE); 3 Recommendation 11 Ad hoc WGHE; 4, 5 Recommendation 14 ad hoc WGHE.
Both dermal and oral exposures have been considered in a worst-case basis.
According to the Recommendation 11th of the Ad hoc working group on human exposure, adults
will ingest the amount applied to fingers. The surface of the fingers is approximately 4% of the
treated body surface. The oral exposures for the age groups < 12 years is calculated for the whole
hands, i.e. approximately 8% of the treated body surface (head, arms, hands, legs and feet according
to US EPA Child-Specific Exposure Factors Handbook, 2002), with a 100 % of transfer coefficient.
In this scenario where the biocidal product is applied directly on the body areas, the exposure is
expected to happen per dermal and oral route.
The following calculations model a scenario where the biocidal product is lodged onto the skin,
leading to both dermal absorption due to direct contact with the skin after spraying; and oral
absorption by hand-to-mouth transfer. The RMS acknowledges, that, since both procedures might
take place at the same time, the calculation should take into account, out of the total amount of
biocide product applied on the skin, that the quantity absorbed per dermal route will not be available
to be in-taken per oral route and vice versa.
The amount of active substance absorbed per dermal and oral route has been calculated based on the
following formulas:
Internal dermal dose a.s. = External dermal dose product × (content a.s.) × (% dermal absorption)
Internal oral dose a.s. = External oral dose product × (content a.s.) × (% oral absorption)
Total dose a.s. = Internal dermal dose a.s. + Internal oral dose a.s.
Where,
External dermal dose product = amount of applied biocidal product that will be lodged over the skin (mg).
External oral dose product = amount of the biocidal product will be ingested (mg)
Content a.s. = concentration of the active substance (mg/100mg)
% dermal absorption = fraction
% oral absorption = fraction
In line with the reverse scenario proposed by UK Proforma, the amount of product (external dose)
that can be applied to a person without exceeding the AELrepeated is:
mg Biocidal product (external dose) = AELa.s. /Total dose a.s. (calculated)
The complexity lies in the fact that the quantity absorbed by the dermal route will not be available to
be ingested; and on the contrary.
For adults, the ratio mg active substance/ mg biocidal product has been calculated assuming i.e. that
an adult intakes the entire amount of product rubbed onto their fingers, which assuming a linear
relation, is the 4% of total amount. Therefore, a 96% of the product will be left on the skin, available
for dermal absorption.
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
AELrepeated a.s = 96 % dermal route + 4% oral route
For adults, if 1 mg of GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY is applied,
the latter proportion would imply that 0.96 mg of the biocide product will be lodged over the skin,
whilst 0.04 mg of the biocide product will be ingested by the adult.
1 mg Biocidal product = 0.96 mg per dermal route + 0.04 mg per oral route
Considering the concentration of DEET is 45 %, a default dermal absorption of 11 % and an oral
absorption of 100 % the corresponding total internal dose is calculated as follows:
Dermal route
0.96 mg Biocidal product x (45 mg DEET/100 mg Biocidal product) x (11 mg DEET/100 mg DEET)
= 0.0445mg DEET internal
Oral route
0.04 mg Biocidal product x (45 mg DEET/100 mg Biocidal product) x (100 mg DEET/100 mg
DEET) = 0.0180 mg DEET internal
Total dose DEET
0.0445 mg internal DEET per dermal route + 0.0180 mg internal DEET per oral route =
0.0655 mg internal DEET / mg GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
For every mg of GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY applied on an
adult’s skin, considering both oral and dermal exposures (since none of the exposures could occur
separately) 0.0655 mg of DEET would be absorbed.
Considering an AEL of 8.2 mg/kg bw/day, the amount of product that can be applied on an adult
without exceeding the AEL is:
8.2 mg DEET/kg bw/day x 1 mg Biocidal product/0.0655 mg DEET = 125 mg of Biocidal product/kg bw/day
That implies that 125 mg/Kg bw/day of GOIBI XTREME FORTE REPELENTE DE INSECTOS
SPRAY can be applied on adult skin before reaching the AEL (limit dose).
For children, the ratio mg active substance/ mg biocidal product has been calculated assuming i.e.
that a child intakes the entire amount of the product rubbed onto their hands, which assuming a
linear relation, is the 8% of total amount. Therefore, a 92% of the product will be left on the skin,
available for dermal absorption.
AELrepeted a.s = 92 % dermal route + 8% oral route
For children, If 1 mg of GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY is
applied, this proportion would imply that 0.92 mg of the biocide product will be lodged over the
skin, whilst 0.08 mg of the biocide product will be ingested by the child.
1 mg Biocidal product = 0.92 mg per dermal route + 0.08 mg per oral route
Dermal route
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
0.92 mg Biocidal product x (45 mg DEET/100 mg Biocidal product) x (11 mg DEET/100 mg DEET)
= 0.0455 mg DEET internal
Oral route
0.08 mg Biocidal product x (45 mg DEET/100 mg Biocidal product) x (100 mg DEET/100 mg
DEET) = 0.0360 mg DEET internal
Total dose DEET
0.0455 mg internal DEET per dermal route + 0.0360 mg internal DEET per oral route =
0.0815 mg internal DEET / mg GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
For children, for every mg of GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
applied on the skin of a child, considering both oral and dermal exposures (since none of the
exposures could occur separately) 0.0815 mg of DEET would be absorbed.
Considering the value of the AEL 8.2 mg/kg bw/day, the amount of product that can be applied on a
child in order not to exceed the AEL is:
8.2 mg DEET/kg bw/day x 1 mg Biocidal product/0.0815 mg DEET = 101 mg of Biocidal product/kg bw/day
That implies that 101 mg/Kg bw/day of GOIBI XTREME FORTE REPELENTE DE INSECTOS
SPRAY can be applied on child skin before reaching the AEL (limit dose).
The number of applications and the maximum area of skin (cm2) that can be treated in one day with
the biocide product ”limit dose” so that the AEL is not exceded has been calculated (Table 2.7.2.2-
1). The calculation taking into account the efficacy of the product as is recommended by the
implementing decision (EU) 2018/1477. As worst case, the efficacy of product GOIBI XTREME
FORTE REPELENTE DE INSECTOS SPRAY (1.15 g product/600 cm2 of skin) has been used for
calculation.
The surface areas from the Recommendation 14 of the Ad hoc working group human exposure are
used for exposure calculations,assuming that the head, trunk, arms, hands, legs and feet are treated.
The trunk has been included by the RMS in the worst case exposure calculation, as a possible body
part to spray on, since the product can be used person in wearing swimming suits and therefore with
the trunk exposed,
In addition, as the product GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY is a
ready-to-use spray with cap dispenser of 0.14 ml (see section 2.2.2) the number of sprays; the
number of applications and the maximum skin area that can be treated in one day (so called ”limit
dose”) have been calculated.
Table 2.7.2.2-1. Number of applications, amount product “limit dose” and area of skin treated with
product “limit dose
Scenario Adults/Child > 12
years
Child 6 to < 12
years
Child 2 to < 6
years
nº application/day 1 1 1
Concentration DEET (% w/w) 45 45 45
AELdermal (mg a.s./kg bw/day) =
Application rate "safely"
8,2 8,2 8,2
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
Scenario Adults/Child > 12
years
Child 6 to < 12
years
Child 2 to < 6
years
Body weight (kg) 60 23,9 15,6
Dermal absorption (%) 11 11 11
Oral absorption (%) 100 100 100
Amount of PRODUCT applied to
reach repeted AEL (mg product
/Kg/day)
125 101 101
Amount of PRODUCT applied to
reach repeted AEL (mg product
/day)
7509 2403 1569
Amount of spray in a single spray
spot (mg)
140 140 140
Number of sprays / day 54 17 11
Eficcacy (1,15 g/600 cm2) 0.0019 0.0019 0.0019
Area of skin that can be treated
with product in one day [cm2]
3918 1254 819
Body surface (cm2) 16600 9200 6800
Number of applications / day 0,2 0,1 0,1
% skin that can be treated in a day 24 14 12
2.7.2.3 Exposure to residues in food
Not relevant, as no contamination of food is expected if users follow the label instructions.
2.7.3 Risk Characterisation
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY is a spray containing 45 % DEET.
There are no ingredients considered as substances of concern. Therefore, only DEET is included in
the risk characterisation.
The maximum skin area that can be applied the pre-defined subpopulations without exceeding the
AEL, is compared to the treated area surface (head, trunk, arms, hands, legs and feet) to show how
many applications/day will be acceptable. Additionally, the number of spray spots/day can be
included.
2.7.3.1 Risk for Professional Users
The product is not intended for professional use.
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
2.7.3.2 Risk for non-professional users and the general public
The exposure assessment for GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY is
expressed as the estimated amount product that can be applied without exceeding the AEL (so
called “limit dose), as well as the area of skin to be treated and the number of applications and
number of sprays are presented in Table 2.7.3.2-1.
As a worst-case approach, the oral exposure has also been performed the assessment, considering the
potential ingestion of a 4% out of the total applied product by adults (amount on fingers) and the
potential ingestion of the 8% out of the total applied product by children
Table 2.7.3.2-1. Amount product “limit dose” and area of skin treated with product “limit dose”.
Scenarios
Adults/Child > 12
years
Child 6 to < 12
years
Child 2 to < 6
years
Amount product “limit dose”
(mg product/kg bw/day) 127 101 101
Amount product “limit dose
(mg product/day) 7509 2403 1569
Area of skin treated in one day
(cm2) with “limit dose”
3918 1254 819
% skin that can be treated 24 14 12
Number of sprays 54 17 11
Number of applications 0.2 0.1 0.1
The recommended maximum skin area to be treated in one day to reduce exposure is show below.
The default values for the body surfaces are based in the Recommendation 14 Ad Hoc working
group human exposure.
There are different ways of phrasing the maximum dose recommendation. For clarification purposes,
the following wording has been decided:
-An adult can be treated a maximum of 3918 cm2 of area of skin. Apply in a uniform manner on
face, lower arms, backs hands and lower legs (3931 cm2).
-Children of 6 to < 12 years can be treated a maximum of 1254 cm2 of area of skin. Apply in a
uniform manner on face, neck, lower arms and upper feet (1313 cm2).
-Children of 2 to 6 years can be treated a maximum of 819 cm2 area of skin. Apply in a uniform
manner on face, neck and lower arms (874 cm 2).”
The reverse dose calculations for exposure show that the 72 to 56% of the estimated internal dose
per application (8.2 mg product/kg/d) of use for adults and children < 12 years respectively, can be
absorbed on skin and the 22 % can be ingered before an AELrepeated is exceeded.
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
Although the oral exposure represents the worst-case risk determines that the oral exposure should
not be overruled especially in case for children < 12 years old. However, according to the CAR of
DEET the oral dose is likely to be overestimated given the DEET short half-life after oral exposure
in dogs and rats and the rapid achievement of Cmax. The hand to mouth behaviour is more frequent
in small children and taking into account that Bitrex may not be sufficiently effective to protect
small children, an age limit of 2 years has been proposed together with the recommendation “restrict
the use on children between three and twelve years old”.
The maximum skin area that can be treated without exceeding the AEL is compared to surface to be
treated, in order to show how many applications/day will be acceptable before reaching the AEL
(Table 2.7.3.2-2).
Additionally, the number of spray spots/day is included. Each spray spot contains 0.14 ml of
biocidal product (aprox. 140 mg), so the number of spray spots to apply not to exceed the AEL,
equals:
number of spray spots /day = mg product/person/day (limit doses) / mg spray spot
Table 2.7.3.2-2. Risk indicator value
Scenarios Adults/Child > 12 years Child 2 to < 6 years
Child 6 to < 12
years
Skin treated in one day (%) 24 14 12
Nº applications/day 0.2 0.1 0.1
Nº sprays/day 54 17 11
Body areas which can be
treated
face, lower arms, backs
hands and lower legs
face, neck, lower
arms and upper feet
face, neck and
lower arms
Therefore, for adults, children < 12 years of age and children > 12 years of age the number of
applications/day is 0.2. 0.1 and 0.1 respectivaly. The number of applications per day does not cover
the area that needs to be treated for adults, children 2 to <6 years and children 6 to <12 years.
For adults, the number of applications covers the 24 % of the area that could be treated; and for
children approximately the 14 % to 12% of the area that could be treated.
The number of spray spots/day for an adults, children < 12 years of age and children > 12 years is
54, 17 and 11 respectivaly. The label instruction needs to be clear and easy to follow to the average
reader. The user is unlikely to comprehend a recommendation expressed as number spray spots per
day.
The CAR of DEET requires the inclusion of a recommendation on maximum skin areas to be treated
to reduce exposure
In summary, the risk characterization performed, considering both dermal and oral routes concludes
that there is risk for each subpopulation (adults, children < 12 years of age, and children > 12 years
of age). The product can be used once per day, on adults and children over 2 years of age. Children’s
hands must not be treated with this product. Children under 2 years must not be treated with this
product.
The RMS is in the opinion that not authorizing GOIBI XTREME FORTE REPELENTE DE
INSECTOS SPRAY would result in disproportionate negative impacts for society when compared to
the risks to human health. It should be taken into account that insect repellents are essential to
prevent vector borne diseases. Also, the availability of insect repellents containing different active
substances is necessary to minimize the occurrence of resistance in the target harmful organisms.
There is an immediate need to maintain a number of insect repellent products containing DEET on
the market in order to protect human health.
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
In consequence, the RMS is in the opinion that GOIBI XTREME FORTE REPELENTE DE
INSECTOS SPRAY must be authorized on the grounds of Article 19(5) of Regulation (EU) No
528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the market and
use of biocidal products.
This authorization is granted under the following conditions:
Once a consensus is reached and the efficacy methods are refined, the applicant commits to provide
new efficacy data. At that point, the competent authorities will re-evaluate the human health risk
assessment, and will take the appropriate regulatory measures, if necessary. Until then, the existence
of risk for human health cannot be overruled.
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY must not be used by children
younger than two years old.
Children must not handle or apply the product by themselves.
The application for adults and children over 2 years of age must be restricted to one application a
day and the area of skin that can be treated safely with the product should be taken into account.
2.7.3.3 Risk for consumers via residues
The acute or chronic exposure to residues in food resulting from the intended uses is unlikely to
cause a risk to consumers. Regarding consumer health protection, there are no objections against the
intended uses.
2.8 Risk assessment for the environment
2.8.1 Fate and distribution in the environment
The environmental fate and behaviour of the active substance DEET has been fully evaluated during
its assessment for Annex I inclusion. A summary of the fate and distribution of DEET is presented in
Section 2.2.2.1 of the final Assessment Report (11 March 2010), and the relevant endpoints appear
in the EU List of Endpoints.
DEET is considered to be ready biodegradable and no major (>10%) transformation products were
formed in studies of hydrolysis and aquatic phototransformation. DEET is extensively metabolised
and excreted through the urine in all assessed mammals, and because the parent structure is ready
biodegradable, and the metabolite structures found in urine do not differ significantly from the
parent structure it is likely that they are also ready biodegradable. It causes only minor inhibitory
effects on (STP) microbial activity.
DEET is moderately volatile and absorbs UV in the region 200-250 nm. The substance is predicted
to have an atmospheric half-life of 0.63 days (15.2 hours). An extensive accumulation of DEET in
air and long range transport is unlikely. DEET is a liquid at room temperature, and it has a water
solubility of 11.2 g/L and its log Pow is 2.4. It is hydrolytically stable under acidic, basic and neutral
conditions, and photolytically stable in sterile distilled water.
Based on the calculated BCFs for aquatic and terrestrial organisms, DEET is considered to have very
little or no potential to bioaccumulate.
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
DEET has a Koc of 43.3, suggesting that it is very mobile in soil and therefore could leach to the
groundwater. However, DEET will not be directly emitted to soil and exposure is expected to be
negligible.
The following statement appeared in Section 3.4 (Requirement for Further Information) of the final
Assessment Report (11 March 2010);
“It is considered that the evaluation has shown that sufficient data have been provided to verify the
outcome and conclusions, ands permit the proposal for the inclusion of N,N-diethyl-meta-toluamide
(DEET) in Annex I to Directive 98/8/EC.
However, further validation data to prove the applicability of the proposed analytical method for the
water compartment is considered needed (The applicant has stated that further validation work is
underway and the data will be submitted as soon as possible).”
According to verbal information: the CAR request was completed and submitted to the KEMI, who
is the CA for DEET. They accepted the method with no questions.
The formulation of DEET in GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY has
no impact on the route or rate of degradation of the active substance DEET in the environment. So it
was concluded that no additional studies involving the formulated product are required.
DEET is used in products for repellents (PT19 Scenario, Repellents and attractants). An ESD has
been published for repellents (PT19) on June 2015, and ES CA has used it for calculation of releases
to the environment.
2.8.2 Effects on environmental organisms
No studies have been conducted with the biocidal product. Reference is made to the active substance
data; no effects are expected which cannot be predicted from the acute toxicity of the active
substance. In Doc II-A of CAR, section 4.2.1, calculations of PNEC values for surface water are
presented. Values are presented below for organisms of three trophic levels.
LC50 fish = 97 mg/L
LC50 invertebrates = 75 mg/L
ErC50 algae = 43 mg/L
No marine species were tested. The applicant argues that these are not necessary based on the
presence of studies performed on freshwater species, all suggesting low toxicity. Besides, DEET will
not be used or released in marine environments in considerable amounts. The effect of DEET on
microbial activity in water was assessed by determining the level of inhibition of respiration of
microorganisms present in activated sludge. DEET had only a minor inhibitory effect on aquatic
microbial activity (26.8% inhibition at the highest tested concentration, 1000 mg/L).
The PNEC values for the water compartment and microorganisms can be calculated from toxicity
data by using recommended assessment factors. Because only three acute aquatic tests were
performed, all on freshwater species, the assessment factor for the freshwater compartment will be
1000 and for the marine water compartment 10 000 (assuming a greater species sensitivity
distribution and thus greater uncertainties in extrapolation of data from the freshwater to the marine
environment; or lower species diversity resulting in high ecosystem dependency).
For the sediment and soil compartments, there are no toxicity data available. The low Koc value
indicates that sorption to sediment and soil is not likely. Nevertheless, PNEC values have been
calculated based on equilibrium partitioning theory (Eq.P.) and PNECwater. The formulas used
assume uptake from the water phase only. This assumption is accepted for DEET, because of its low
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
log POW and KOC values. No quantitative estimation of PNECmarine sediment is necessary
because the PEC values for the marine sediment compartment will be based on EqP and the same
POW and Koc values. The PEC/PNEC ratios for the marine sediment compartment will therefore be
the same as for the corresponding water compartment.
PNECs were not calculated for the air compartment, as there are no data on biotic effects in the
atmosphere. Furthermore, DEET is not expected to be subject to long range air transport (half life is
less than 2d), or contribute to global warming (although the substance has a vapour pressure higher
than 0.01 Pa, the Henry´s law constant is low and DT50 is less than 2d; cf the TNsG on Annex I
inclusion), ozone depletion in the stratosphere (atmospheric lifetime is <<1year, and it does not
contain Cl, Br or F substituents) or acidification (the AP, Acidification Potential is low).
The log POW is 2.4, suggesting a low bioaccumulation potential (BCF estimates range between 3.85
and 63.1), see doc II-A 4.1.4 of the Assessment Report. The risk of secondary poisoning is therefore
expected to be low via ingestion of potentially contaminated food (e.g., fish) by birds or mammals.
The risk for secondary poisoning via intake of terrestrial organisms such as earthworms is
considered unlikely also because exposure to earthworms is expected to be negligible. No avian
dietary tests were therefore required. The available avian acute lethality data are not appropriate for
extrapolation to chronic dietary uptake conditions (cf TGD II3.8.3.5). PNECs were therefore not
calculated for oral uptake from the food chain (to quantify the risk of secondary poisoning).
According to the CAR the effects assessment is summarized in the following table:
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
Table 2.8.2-1. PNECs for the environmental compartments
Compartment Available data Assessment factor/Eq P Remark PNEC
Freshwater LC50dapnia: 75 mg/L LC50fish: 97 mg/L EC50algae: 43 mg/L 1000
No chronic data available (except for NOEC algae)
43/1000= 0.043 mg/L
Saltwater LC50daphnia: 75 mg/L LC50fish:97 mg/L EC50algae: 43 mg/L 10.000 (TGD II4.3.1.3)
No chronic data available (except for NOEC algae), and no additional marine data
43/10000= 0.0043 mg/L
STP microorganismos
EC50: >1000 mg/L NOEC: 300 mg/L
For EC50: 100 For NOEC: 10
At the highest test concentration (1000 mg/L) there was 26.8% inhibition. At NOEC, there was 13% simulation rather than inhibition.
>1000/100 = >10 mg/L
Sediment, freshwater
Measured Koc: 43.3 Default assumptions: RHOwater: 1000 kg/m3 Fwatersusp: 0.9 Fsolidsusp:0.1 RHOsolid: 2500 kg/m3 Focsusp: 0.1 (TGD II 2.3.4 table 5)
PNECsed: 1000*PNECwater*(Ksusp-water/RHOsusp) (TGD II 3.5.3 eq70) Where: RHOsusp: Fsolidsusp*RHOsolid+Fwatersusp*RHOwater And Ksusp-water: Fwatersusp + Fsolidsusp*RHOsolid*(FOCsusp*Koc)/1000
RHOsusp=0.1*2500+0.9*1000=1150 kg/m3 Ksusp-water= 0.9+0.1*(0.1*43.3*(1.98/1150)=0.0741 mg/kg ww
1000*0.043*(1.98/1150)=0.074 mg/kg ww
Soil
Measured Koc: 43.3 Henry´s law constant: 3.93E-03 Pa*m3/mol Default assumptions: R (gas constant)= 8.314 Pa*m3/(mol*K) Temp:285 Fairsoil:0.2 Fwatersoil:0.2 Fsolidsoil: 0.6 Focsoil: 0.02 RHOair: 1.3 kg/m3 RHOsolid: 2500 kg/m3 RHOwater: 1000 kg/m3 (TGD II 2.3.4. and 2.3.5.2)
PNECsoil: 1000*PNECwater*(Ksoil-
water/RHOsoil) (TGD II3.6.2.1) Where: RHOsoil: Fsolidsoil*RHOsolid+Fwatersoil*RHOwater+Fairsoil*RHOair Ksoil-water: Fairsoil*Kairwater+Fwatersoil+Fsolidsoil*(Kpsoil/1000)*RHOsolid and Kpsoil=Focsoil*Koc and: Kair-water=HENRY/(R*temp)
RHOsoil= 0.6*2500+0.2*1000+0.2*1.3=1700 kg/m3 Kair-water: 3.93E-03/(8.314*285)=1.66E-06 Kpsoil: 0.02*43.3=0.866l/Kg ksoil-water= 0.2[3.93E-03/(8.314*285)]+0.2+0.6*[0.866/1000]*2500=1.499
1000*0.043*(1.499/1700)= 0.0379 mg/kg ww
2.8.3 Environmental exposure assessment
A new version for PT19 was published in May 2015. Therefore, ESCA has recalculated predicted
Environmental Concentrations (PEC) in STP, surface water, sediment, soil and groundwater
following this new PT19 Scenario document (Repellents and Attractants) and the Guidance on the
Biocidal Products Regulation (Volume IV Environment – Part B Risk Assessment (active
substances) Version 1, April 2015. The environmental risk assessment has been performed solely for
the active substance as the available tests do not indicate formation of metabolites at a level higher
than 10% of the active substance. It is thereby assumed that the risk assessment for the active
substance also covers for the metabolites.
According to Scenario PT19 Emissions to the environment can take place during the application of
the product on human skin. A fraction can be released to the floor when repellents are applied
indoors or to paved or unpaved ground during outdoor applications. However, according to TM
IV/2013, emissions resulting from the stage of application on human skin are of minor importance
since they take place non-repeatedly on a very limited area and are therefore not considered within
this ESD.
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
The main emissions of this use to the environment occur during the removal phase of the insect
repellent. Removal of the product from human skin can either take place:
Through showering or bathing of humans who have used an insect repellent and/or washing
of the clothes treated with the repellent formulation. Sewage treatment plants are the
primary compartment for emissions whereas surface water bodies (including sediment) as
well as the soil compartment (including groundwater) are secondary exposed compartments
for remnants via sewage treatment plant effluents and sewage sludge applications,
respectively. Major emissions from the application of mosquito and tick repellents result
from indoor showering or bathing with emission via the STP to surface water and sediment (waste phase).
Through direct release to surface water if people with treated skin go swimming in outdoor
surface waters (only for human skin repellents).
The water compartment is therefore expected to be exposed to DEET, and because of the
physiochemical character of the substance, the emissions will continue to primarily remain in this
compartment (supported by level III fugacity modelling). Emission to fresh water is expected to be
worst case. Therefore risk for the marine environment is considered covered by the freshwater risk
assessment.
2.8.3.1 PEC in surface water, sewage treatment plant, ground water and sediment
PEC Sewage Treatment plant for indirect emission through showering and bathing of humans
The emission scenario for calculating the release of repellents used on human skin is based on the
average consumption. According to the Applicant the percentage of active substance in the product
is 45% w/w, the product is applied 1 time per day.
Elocalwater values for skin (Emission rate to wastewater (standard STP), kg/d), i.e. the inflow of
DEET to an STP during an emission episode, can be calculated from the formula below following
the Scenario PT19; meanwhile the respective PECSTP values have been obtained following the BPR
Guidance.
Elocalwater= Nlocal x Nappl x Qformappl x AREAskin/garment x Cformweight x Finh x Fwater x Fpenetr x 10-9
eq (3.8) ESD PT19
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
Table 2.8.3.1-1. Inputs for Elocalwater calculation according to Scenario PT19
Value Unit Origin
INPUTS
Number inhabitants feeding one sewage
treatment plant
Nlocal 10000 cap D
Active substance in the product Cformweight 450 g.kg-1
S
Consumption per application Qformappl 1.916 mg.cm-
2 skin
D/s
Number of applications per day (skin) Nappl,skin 1 d-1
D
Treated area of human skin AREAskin 10660 cm2 P
Fraction released to air Fair 0 - D
Fraction dermally absorbed Fskin 0 - D
Fraction released to wastewater Fwater 1 - D/O
Fraction of inhabitants using a repellent
product
Finh 0.2 - P
Market share of repellent Fpenetr 0.5 - D
Specific density of the product RHOform 1000 kg.m-3
D
Intermediate calculation: Fwater = 1 - (Fair + Fskin) = 1
Table 2.8.3.1-2. Elocalwater according to Scenario PT19
OUTPUT
Local emission rate to wastewater (skin) Elocalwater,skin 9.114 kg.d-1
O
PEC values for skin are calculated according to the BPR Guidance. Following calculations done in
the DEET CAR Clocaleff is used for PECSTP calculation:
Clocalinf = Elocalwater x 106 / EFFLUENTSTP
EFFLUENTSTP = CAPACITYSTP x WASTEWinhab = 2000000
PECSTP = Clocaleff (Continuous release) = Clocalinf x FSTPwater eq (33)
Table 2.8.3.1-3. PECSTP calculation
Value Unit Origin
INPUTS
Concentration in untreated wastewater (skin) Clocalinf,skin 4.557 mg.L-1
BPR
Guidance
Fraction of emission directed to water by STP FSTPwater 0.126 - EUSES/D
TGD
OUTPUT
PECSTP,skin = Clocaleff,skin 0.574 mg.L-1
O
PEC in surfacewater and sediment
In this section, the local concentration in surface water during emission episode is derived. It can be
distinguished between indirect releases to surface water, when another environmental compartment
(e.g. STP) is exposed before or direct release, i.e. indirect emissions through showering and bathing
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
of humans and when surface water is the first receiving environmental compartment, i.e. direct
emissions through swimming.
Indirect release:
PEC Surface water:
According to the BPR Guidance:
PEClocalwater = Clocalwater = Clocaleff / [(1 + kpsusp x SUSPwater x 10-6
) x DILUTION] eq (45)
BPR Guidance
Where
Kp,susp = Focsusp x Koc eq. (23) BPR Guidance
Table 2.8.3.1-4. Inputs for Kp,susp calculation
Weight fraction organic carbon in suspended matter
(Focsusp)
0.1 kg.kg-1
table 5
BPR
Guidance
Part.coef. Carbon-water 43.3 L.kg-1
S
Table 2.8.3.1-5. Model inputs and outputs for PEClocalwater calculation indirect release
Value Unit Origin
INPUTS
Concentration of the substance in the
STP effluent (skin)
Clocaleff,skin 0.574 mg.L-1
BPR
Guidance
solids-water partitioning coefficient of
suspended matter
Kp,susp 4.33 L.kg-1
eq (23)
BPR
Guidance
Concentration of suspended matter in the
river
SUSPwater 15 mg.L-1
D
Dilution factor DILUTION 10 - D
OUTPUT
PEClocalwater,skin = Clocalwater,skin 0.0574 mg.L-1
O
PEC sediment
According to the BPR Guidance:
PEClocalsed = (Ksusp-water / RHOsusp) x PEClocalwater x 1000 eq (50) BPR Guidance
Where:
Ksusp-water = Fwatersusp + [Fsolidsusp x (Kpsusp / 1000) x RHOsolid] eq (24) BPR Guidance
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
Table 2.8.3.1-8. Input for calculation of Ksusp-water
Fraction water in susp.matter 0.9 m3.m
-3 Table 5 BPR
Guidance
Fraction solids in susp.matter 0.1 m3.m
-3 Table 5 BPR
Guidance
solids-water part. Coef. of susp 4.33 L.kg-1
eq. (23) BPR
Guidance
Density of the solid phase 2500 kg.m-3
D
Table 2.8.3.1-9. Inputs and outputs table for the calculation of PEClocalsediment indirect release
Concentration in surface water during
emission episode (skin)
PEClocalwater,skin 0.0574 mg.L-1
eq. (45) BPR
Guidance
Suspended matter-water partitioning
coefficient
Ksusp-water 1.9825 m3.m
-3 eq. (24) BPR
Guidance
Bulk density of suspended matter RHOsusp 1150 kg.m-3
eq. (18) BPR
Guidance
OUTPUT
PEClocalsed,skin = 0.0989 mg.kg-1
O
Direct release:
PEC surface water:
The estimation of the direct local PECs for the aquatic compartment only includes surface water and
sediment for the swimming-pathway because of direct entry of B.P. in the environment.
According to ESD PT19, the local emission rate to surface water body (Elocalwater) can be calculated
from the formula (Table 3-7 [3.12]):
Elocalwater = Nswimmer * Nappl * Qformappl * AREAskin * Cformweight * Fswim * Fwaterbody * 10-9
The input values used to estimate Elocalwater are summarized in the table below:
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
Table 2.8.3.1-6. Model inputs and outputs for Elocalwater calculation direct release.
parameters
(abbrev)
Value Unit Remarks
INPUTS
Nswimmers Daily number of swimmers 1500 - Set per default (see Appendix
6.3. ESD PT19).
Fswim Fraction of swimmers using the
repellent product
0.1 - As a best guess it is assumed,
that 2% of the swimmers use
an insect repellent before
entering the surface water
body. This value of 0.02 for
Fswim should be used as
default value for active
substance approval.
However, for product
authorisation a higher value
(0.1) can be appropriate, to
cover areas with higher
insect infestation.
Nappl Number of applications per day 1 d-1
According to Schets et al.
(2011) visits of swimmers at
Dutch fresh- and seawater
sites lasted 41-79 minutes per
occasion in 2007 and 2009. It
can be expected that during
this time period, treatment
with a repellent will take
place only once.
Fwaterbody Fraction released to surface water
body
1 - Set per default.
Cformweight Active substance in the product 450 g.kg-1
18% (information submitted
by the applicant).
Qformappl Consumption per application 1.916 mg.cm-2
skin
D
AREAskin Treated area of human skin 16660 cm2 D (see Table 3-3 ESD PT19).
RHOform Specific density of the product 1000 kg.m-3
D
OUTPUT
Local
emission
rate to
surface
water
Elocalwater 2.128 kg.d-1
O
The surface water concentrations following swimming of humans having used an insect repellent on
their skin are calculated with these equations:
Clocalwater,1d = Elocalwater * 103 * Temission,1d / Vwaterbody (3.13 ESD PT19)
Clocalwater,91d = Elocalwater * 103 * Temission,91d / Vwaterbody
(3.14 ESD PT19)
Clocalwater,91d−ref = Clocalwater,1d[1−(e−kdegwater∗Temission,1d
)Nemission,91d
/ 1−e−kdegwater∗Temission,1d
] (3.15 ESD
PT19)
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
Table 2.8.3.1-7. Input values used to estimate PEClocalwater direct release
parameters
(abbrev)
Value Unit Remarks
INPUTS
Elocalwater Local emission rate to surface water 2.128 kg.d-1
-
Vwaterbody Volume of waterbody 435000 m3 D
Kdegwater 1st order rate constant for
biodegradation in surface water
0.047 d-1
The rate constant for
biodegradation in surface
water for readily
biodegradable substances can
be taken from Table 7 of the
Technical Guidance
Document (k = 0.047 d-1
; EC,
2003).
Temission,1d Number of emission days 1 d Concentrations of the
repellent have to be
calculated for emission
periods of 1 day and 91 days.
Temission,91d Number of emission days 91 d Concentrations of the
repellent have to be
calculated for emission
periods of 1 day and 91 days.
Nemission,91d Number of emission events 91 - -
As a first tier approach, the PEClocalwater corresponds to Clocalwater,91d from equation 3.14 and should
be used for the risk assessment, representing the worst-case situation. Therefore, PEClocalwater,91d is
0.445 mg/L.
Calculation of PEClocalwater according to Clocalwater,91d-ref (equation 3.15) provides a refinement
option considering degradation processes in the water body. This approach is based on equations 4,
7 and 8 of the ESD for PT 18 (OECD ESD No. 14 (insecticides for stables and manure storage
systems); OECD, 2006). Therefore, PEClocalwater,91d-ref is 0.105 mg/L.
PEC sediment
PEC sediment for direct emission to the aquatic environment is calculated based on the BPC
Guidance and the PEC direct values obtained for surface water.
PEClocalsed = (Ksusp-water / RHOsusp) x PEClocalwater x 1000 eq (50) BPR Guidance
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
Table 2.8.3.1-10. Inputs and outputs table for the calculation of PEClocalsediment direct release
Value Unit Origin
INPUTS
Concentration in surface water during emission
episode (1st Tier)
PEClocalwater,91d 0.0903 mg.L-1
eq. (3.14)
Concentration in surface water during emission
episode (2nd Tier)
PEClocalwater,91d-
ref
0.0213 mg.L-1
eq. (3.15)
Suspended matter-water partitioning coefficient Ksusp-water 1.9825 m3.m
-3 eq. (24)
BPR
Guidance
Bulk density of suspended matter RHOsusp 1150 kg.m-3
eq. (18)
BPR
Guidance
OUTPUT
PEClocalsed,91d = 0.767 mg.kg-1
O
PEClocalsed,91d-ref = 0.181 mg.kg-1
O
2.8.3.2 PEC in air
DEET has a vapour pressure of 0.23 Pa (25°C) /EU Endpoint List/ and a Henry’s law constant of
3.93E-03 Pa*m3/mol /EU Endpoint List/. The substance is predicted to have an atmospheric half-life
of 0.63 days (15.2 hours) /EU Endpoint List/. Thus an accumulation of DEET in air and long range
transport is unlikely. As the substance unlikely shows significant long-range transport, it is
considered of no concern for ozone depletion. According to the TGD II, in IC5, UC36 (cosmetic
odour agents; p 226), 5% of the applied amount (for substances having vapour pressure below 100
Pa) is assumed to be emitted to the air. However the half life is below the trigger value of < 2 days
that is used as cut-off value to identify chemicals that could be of potential concern. The PEC of
DEET in air is therefore considered to be negligible and the substance will not pose a risk to the
atmospheric environment. Therefore no risk assessment is performed for the atmospheric
environment.
2.8.3.3 PEC in soil
PEC in agricultural soils is used for risk characterisation of terrestrial ecosystems. According to the
BPR Guidance section 2.3.8.5 it can be distinguished between indirect releases (i.e.: release via
sewage sludge application from a STP) or direct releases when soil is the first receiving
environmental compartment. However, most relevant direct emissions result from outdoor
swimming and bathing after application of the product, important direct emissions to soil are
therefore not expected. Besides, scenario PT 19 does not contemplate direct emissions to soil.
Indirect release
Exposure to soil via the sewer system can occur through application of sewage sludge from a STP,
which can be used as a fertiliser or soil improver. The concentrations in soil arising from such
application of sewage sludge will depend on the concentration of DEET in sludge, the amount of
sludge applied to soil, and the volume of soil mixed with the sewage sludge.
In this section the following endpoints and underlying parameters are derived both for skin:
Local concentration in soil (averaged for a certain time period)
Local concentration in agricultural soil (averaged over a certain time period)
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
Local concentration in grassland ( averaged over a certain time period)
The concentration at the regional scale is used as background concentration for the local scale and
refers to the concentration in unpolluted soil resulting from deposition only. But as deposition is not
considered to be a relevant exposure process the Predicted Environmental Concentration for local
soils (PEClocal) is equal to the Clocal for soils.
PEClocalsoil = Clocalsoil = (1/kT) x Csoil 10 (0) x (1 - e-kT
) Eq (66) (55) BPR Guidance
Table 2.8.3.3-1. Inputs and outputs table for the calculation of PEClocalsoil indirect release
Value Unit Origin
INPUTS
Averaging time T 30 d Table 11 BPR
Guidance
First order rate constant for removal from
top soil
k 0.0254 d-1
eq. (56) BPR
Guidance
Initial concentration after 10 years (skin) Csoil 10, skin (0) 0.0768 mg.kg-1
eq. (63) BPR
Guidance
OUTPUTS
PEClocalsoil,skin = Clocalsoil,skin 0.0537 mg.kg-1
O
For PEClocalsoil air emissions are not considered because an extensive accumulation of DEET in air
and long range transport is unlikely. A series of equations must be solved before obtaining PEC
values.
Constant k is obtained by applying the following formula:
k = kvolat + kleach + kbiosoil eq (56) BPR Guidance
Table 2.8.3.3-2. Calculation of constant k
INPUT
kvolat 0.0007 d-1
eq. (57) BPR Guidance
kleach 0.0016 d-1
eq. (58) BPR Guidance
kbiosoil 0.0231 d-1
eq. (29) BPR Guidance
OUTPUT
k 0.0254 d-1
Eq (56) BPR Guidance
The rest of the values are obtained following this step-wise procedure. In accordance with BPR
Guidance the initial concentration in year 10 is:
C soil10 (0) = Csludgesoil 10 (0) = Csludgesoil 1 (0) x [1 + ∑9n=1Faccn] + Cdepsoil10 eq (6
2/63) BPR Guidance
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
Table 2.8.3.3-3 Inputs and outputs for C soil10 (0) calculation
Value Unit Origin
INPUTS
Concentration in soil due to sludge in first
year at t=0 (skin)
Csludgesoil,skin
1(0)
0.076 mg.kg-1
eq. (60)
BPR
Guidance
Fraction accumulation in one year Facc 9.516E-
05
- eq. (61)
BPR
Guidance
OUTPUT
Csoil 10, skin (10) = Csludgesoil 10 (0) = Csludgesoil,skin
1(0)
0.0537 mg.kg-1
O
Since the fraction of accumulation equals to 0 Csoil 10 (0) = Csludge 1 (0)
The concentration of DEET in soil, just after the first year of sludge application, is estimated in the
following way:
Csludgesoil 1(0) = (Csludge * Applsludge)/ (DEPTHsoil * RHOsludge) eq. (60) BPR Guidance
Table 2.8.3.3-4. Inputs and outputs for Csludgesoil 1(0) calculation
INPUT
Concentration in dry sewage sludge
(skin)
Csludge, skin 52.24 mg.kg-1
eq. (36)
BPR
Guidance
Dry sludge application rate APPLsludge 0.5 kg.m-2
.yr-1
Table 11
BPR
Guidance
Mixing depth of soil DEPTHsoil 0.2 m Table 11
BPR
Guidance
Bulk density of soil RHOsoil 1700 kg.m-3
eq. (18)
BPR
Guidance
OUTPUT
Csludgesoil,skin 1(0) 0.076 mg.kg-1
O
Where Csludge (concentration in sewage sludge) is:
Csludge = (FSTPsludge * Elocalwater *106) / SLUDGERATE eq (36) BPR Guidance
Table 2.8.3.3-5. Inputs and outputs for Csludge calculation
INPUT
Fraction of emis. to sludge by STP 0.00407 - EUSES
Local em. rate to water during episode (skin) 9.114 kg.d-1
PT-19
Rate of sewage sludge production (SLUDGERATE) 710 kg.d-1
eq. (37) BPR
Guidance
OUTPUT
Concentration in dry sewage sludge (skin) 52.246 mg.kg-1
eq. (36) BPR
Guidance
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
Where:
SLUDGERATE= 2/3 * SUSPCONCinf * EFFLUENTSTP + SURPLUSsludge * CAPACITYSTP eq.
(37) BPR Giudance
Table 2.8.3.3-6. Inputs and outputs for SLUDGERATE calculation
INPUT
Concentration of suspended matter in STP
influent
0.45 kg.m-3
Table 9 BPR Guidance
Effluent discharge rate of STP 2000 m3.d
-1 eq. (34) BPR Guidance
Surplus sludge per inhabitant equivalent 0.011 kg.d-1
.eq-1
Table 9 BPR Guidance
Capacity of the STP 10000 eq Table 9 BPR Guidance
OUTPUT
SLUDGERATE 710 kg.d-1
eq (37) BPR Guidance
PEC calculations for agriculture and grassland are obtained using the same formulas but varying the
depth of soil and average time (see table 11 BPR Guidance).
Agric. Soil: PEClocalagr.soil = Clocalagr.soil = (1/kT) x Cagr.soil 10 (0) x (1 - e-kT
) eq
(66) (55)
Table 2.8.3.3-7. Inputs and outputs for PEClocalagr.soil calculation indirect release
Value Unit Origin
INPUTS
Averaging time T 180 d Table 11
BPR
Guidance
First order rate constant for removal
from top soil
k 0.0269 d-1
eq. (56)
BPR
Guidance
Initial concentration after 10 years
(skin)
Cagr.soil 10, skin (0) 0.0768 mg.kg-1
eq. (63)
BPR
Guidance
OUTPUT
PEClocalagr.soil,skin = Clocalagr.soil,skin 0.0166 mg.kg-1
O
2.8.3.4 PEC in groundwater
In order to confirm if the product leaches into groundwater an evaluation was conducted. As an
indication for potential groundwater levels, the concentration in porewater of agricultural soil is
taken. It should be noted that this is a worst-case assumption, neglecting transformation and dilution
in deeper soil layers.
Thus, the predicted environmental concentration in groundwater (PEClocalgroundwater) is equal to the
predicted environmental concentration in porewater (PEClocalagrsoil, porew). In order to calculate the
concentration of the a.s. in porewater, a number of partition coefficients are derived from the
following equations:
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
Ksoil-water = Fairsoil x Kair-water + Fwatersoil + [Fsolidsoil x (Kpsoil / 1000) x RHOsolid]
eq (24) BPR Guidance
Table 2.8.3.4-1. Inputs and outputs for Ksoil-water calculation
Fraction air in soil 0.2 m3.m
-3 Table 5
BPR
Guidance
K Air-water partitioning coeff. 1.6586E-06 - eq. (22)
BPR
Guidance
Fraction water in soil 0.2 m3.m
-3 Table 5
BPR
Guidance
Fraction solids in soil 0.6 m3.m
-3 Table 5
BPR
Guidance
K solids-water part. Coef. of soil 0.866 L.kg-1
eq. (23)
BPR
Guidance
Density of the solid phase 2500 kg.m-3
D
Kair-water = HENRY / R x TEMP (22)
Henry's law constant 0.0039 Pa.m3.mol
-1 S
Gas constant 8.314 Pa.m3.mol
-1.k
-1 D
Temperature air-water interface 285 k D
Kpsoil = Foc,soil x Koc (23)
Weight fraction of org.carbon in soil 0.02 kg.kg-1
Table 5
BPR
Guidance
Partition coeff. Org.carbon-water 43.3 L.kg-1
S
Solving the equations for PEClocal the following results are obtained.
PEClocalgrw = PEClocalagr.soil, porewater = (PEClocalagr.soil x RHOsoil) / (Ksoil-water x 1000) eq (68)(67)
Table 2.8.3.4-2. Inputs and outputs for PEClocalagr.soil, porewater calculation
Value Unit Origin
INPUTS
Predicted environmental conc.
in soil (skin)
PEClocalagr.soil,skin 0.0166 mg.kg-1
eq. (66)(55)
BPR
Guidance
Soil-water partitioning
coefficient
Ksoil-water 1.499 m3.m
-3 eq. (24) BPR
Guidance
Bulk density of wet soil RHOsoil 1700 kg.m-3
eq. (18) BPR
Guidance
OUTPUT
PEClocalgrw,skin = PEClocalagr.soil, porewater,skin 0.0188 mg.L-1
O
PEClocalgrw = PEClocalgrassland, porewater = (PEClocalgrassland x RHOsoil) / (Ksoil-water x 1000) eq
(68)(67)
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
Table 2.8.3.4-3. Inputs and outputs for PEClocalgrassland, porewater calculation
Value Unit Origin
INPUTS
Predicted environmental conc. in soil
(skin)
PEClocalsoil,skin 0.0062 mg.kg-1
eq.
(66)(55)
BPR
Guidance
Soil-water partitioning coefficient Ksoil-water 1.499 m3.m
-3 eq. (24)
BPR
Guidance
Bulk density of wet soil RHOsoil 1700 kg.m-3
eq. (18)
BPR
Guidance
OUTPUT
PEClocalgrw,skin = PEClocalgrassland,
porewater,skin
0.0071 mg.L-1
O
The concentration in groundwater should be <0.1 μg/L for active substance, relevant metabolites or
breakdown/reaction products and substances of concern. Since the values obtained are aboved this
value PECgw was further refined using the nine FOCUS groundwater scenarios, as developed for
plant protection products (see tables 2.8.4.3-4, 2.8.4.3-5 and 2.8.4.3-6).
2.8.3.5 Non compartment specific exposure relevant to the food chain (secondary
poisoning)
DEET log Kow is 2.4, suggesting a low bioaccumulation potential (BCF estimates range between
3.85 and 63.1). The risk of secondary poisoning is therefore expected to be low via ingestion of
potentially contaminated food (e.g., fish) by birds or mammals. The risk for secondary poisoning via
intake of terrestrial organisms such as earthworms is considered unlikely also because exposure to
earthworms is expected to be negligible. No avian dietary tests were therefore required. However,
acute avian toxicity was measured by oral intubation and there was a clear dose-response
relationship regarding both lethality and sublethal effects. DEET was found to have only slight acute
avian toxicity (LD50 1375 mg/kg bw). Sublethal effects (behaviour, appearance and weight loss and
reduced feed intake) appeared relatively soon after dosing, but signs of toxicity disappeared with
time among the survivors.
2.8.4 Risk characterisation for the environment
The risk characterisation for the environment is the comparison of the exposure estimates to the
toxicity of the substance. Both aspects were already discussed in sections 2.8.2 and 2.8.3,
respectively, and only the relevant values are summarised below. The environmental risk has been
assessed solely for the active substance as the available tests do not indicate formation of
metabolites at a level higher than 10% of the active substance. It is thereby assumed that the risk
assessment for the active substance also covers risks for the metabolites.
2.8.4.1 Aquatic compartment (incl. sediment)
Indirect Emissions: Risk assessment for indirect emission via STP through showering and
bathing of humans
Two local scenarios were assessed for indirect emission pathway, considering that the product can
be applied on human skin. PECs for both local scenarios were by using ESD for PT19 and equations
in the BPR Guidance.
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
Estimated local PECs for microorganism (in STP), fresh surface water and sediment were almost
identical in both approaches. As shown below, none of the PEC/PNEC ratios exceed 1, even if based
on worst case local PEC values for skin scenario (Table 2.8.4.3.1-1).
Note that emission to surface water is expected to be worst case. Therefore risk for the marine
environment is considered covered by the surface water risk assessment. Furthermore, no
quantitative estimation of PNECmarine sediment is necessary because the PEC values for the marine
sediment compartment will be based on EqP and the same POW and Koc values. The PEC/PNEC
ratios for the marine sediment compartment will therefore be the same as for the corresponding
water compartment.
Table 2.8.4.1-1. PEC/PNEC ratios for the worst case local scenario for the aquatic compartments during an
indirect emission episode according to ESD 19.
Aquatic Compartment PEC PNEC PEC/PNEC
Microorganisms (STP), skin (mg/L) 0.574 >10 0.0574
Surface Freshwater, skin (mg/L) 0.0574 0.043 1.33
Freshwater sediment, skin (mg/kg) 0.0989 0.0741 1.33
Direct emission through swimming
In table 2.8.4.1-2. the PEC/PNEC ratios for direct emission to surface water and sediment due to
swimming are indicated. The PECs were calculated using ESD PT19. The PEC/PNEC ratios for
TIER 1 both in surface water and sediment are higher than 1 indicating a risk for the environment.
However, for TIER 2, once degradation processes in water are taken into account, the PC/PNEC
ratios for both surface and sediment are lower than 1.
Table 2.8.4.1-2. PEC/PNEC ratios for the worst case local scenario for the aquatic compartments during a direct emission episode.
Aquatic Compartment PEC PNEC PEC/PNEC
Freshwater,91d (mg/L) 0.0903 0.043 2.100
Freshwater,91d-ref (mg/L) 0.0675 0.043 1.56
Freshwater sediment, 91d (mg/kg) 0.493 0.0741 6.65
Freshwater sediment, 91d-ref (mg/kg) 0.116 0.0741 1.57
2.8.4.2 Atmosphere
Although PEC/PNEC ratios could not be calculated, the physiochemical properties of DEET do not
suggest that this substance will pose a significant threat to the atmospheric environment.
2.8.4.3 Terrestrial compartment
Risk assessment for indirect emission via STP through showering and bathing of humans
Exposure to soil via the sewer system can occur through application of sewage sludge from a STP as
a fertilizer or soil improver. Two local scenarios for human skin were assessed for indirect emission
pathway. PECs for both local scenarios were calculated by using ESD for PT19 and equations in the
BPR guidance.
For risk assessment purposes, the PEC soil values calculated using ESD for PT19 were selected as
worst case scenarios. None of the PEC/PNEC ratios exceed 1 (See Table 2.8.4.3-1).
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
Table 2.8.4.3-1. PEC/PNEC ratios for the terrestrial compartments during an indirect emission episode (PEC soil values calculated using ESD for PT19).
ESD PT19
Terrestrial Compartment
PEC
(mg/kg)
PNEC
(mg/kg)
PEC/PNEC
Human skin scenario
Soil 0.053 0.0379 1.41
Agricultural soil 0.0166 0.0379 0.43
Grassland 0.0062 0.0379 0.16
Concerning the PECs for groundwater, estimations on porewater agricultural soil and porewater
grassland using ESD for PT19 were the worst case in both scenarios (See Table See Table 2.8.4.3-
3). Table 2.8.4.3-3. PECs for groundwater for indirect emission to groundwater.
PECporewater agr. Soil
(µg/L)
PECporewater grassland
(µg/L)
Human skin scenario
18.8 7.13
Considering that the calculated PECs for porewater exceed the drinking water limit for groundwater
of 0.1 µg/L, PECgw for the nine FOCUS groundwater scenarios, as developed for plant protection
products, were calculated. Model used, input data and assumptions are shown in table 2.8.4.3-4,
assuming that the only exposure route to groundwater is via the application of sludge from STPs.
Table 2.8.4.3-4. Summary of data used and assumptions made to calculate PECgw for DEET in FOCUS
scenarios.
Parameter Value
Model used: FOCUS PEARL ver. 4.4.4.
Years of simulation: 26 (including 6 yrs "warming-up" period)
Application rate: 0.26 kg/haa
Application method: To the soil surface
Date of application: 1 October annually for 20 yearsb
Molar mass: 191.27 g/mol
Vapour pressure: 0.11 Pa (20°C)
Water solubility: 11200 mg/L (25°C)
Kom: 25.1 L/kgc
Freundlich exponent 1/n: 0.9 (FOCUS default)
DT50 soil: 30 days (12°C)d
Coefficient for uptake in plants: 0 (worst-case assumption) a Calculated from Simple Treat output concentration of DEET in dry sewage sludge of 16.49 mg/kg (see table 2.8.3.3-4.), and application
of 5000 kg dry sludge/ha and year to agricultural land (at a single event as suggested in the BPR Guidance 2.3.8.5).
b Autumn application assumed to represent a worst-case situation.
c Calculated from Koc as 43.3/1.724.
d In accordance with EUSES/TGD, Part II 2.3.6.5., for ready biodegradable substances.
The resulting PECgw (as FOCUS standard output; 80th percentile annual average PECgw at 1 m depth)
are shown in table 2.8.4.3.-5. Concerning a potential contamination of groundwater, four FOCUS
scenarios exceeded the limit of 0.1 µg/L (Hamburg, Okehampton, Piacenza and Porto). Two FOCUS
scenarios represent the Iberian Peninsula: Seville and Porto. Seville does not exceed the limit of 0.1
µg/L, whereas Porto exceed it insignificantly
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
Table 2.8.4.3-5. 80th percentile annual average PEC of DEET in groundwater (at 1 m depth) calculated for
nine FOCUS scenarios, assuming application of sewage sludge from STP to land.
Scenario PECgw, µg/L
(grass)
PECgw, µg/L
(winter cereal)
Chateaudun 0.026 0.0081
Hamburg 0.287 0.322
Jokioinen 0.109 0.635
Kremsmuenster 0.104 0.124
Okehampton 0.284 0.274
Piacenza 0.160 0.125
Porto 0.098 0.088
Sevilla 0.006 0.0006
Thiva 0.0154 0.00154
ES CA considers that the emissions values obtained are overstimated, due to the risk assessment is
based in the consumption scenarios. In the evaluation made in the CAR on DEET, no risk was
identified for groundwater after refinement with FOCUS PEARL in the tonnage based approach. In
addition, repellent products for use on human skin or clothes are sometimes sold in the EU, yet they
are intended to be used in foreign/tropical regions to prevent insect bites which subsequently
minimises the risk of disease infection (e.g. such as malaria which is carried by Anopheles
mosquitoes). Consequently, emissions from the use of these products are not to be expected within
the EU but generally in non-EU countries with a high incidence of disease carrying vectors.
2.8.4.4 Non compartment specific exposure relevant to food chain (primary and
secondary poisoning)
Primary poisoning of birds and mammals due to intake of the product is not expected to be relevant.
Considering the low acute toxicity of DEET to birds (LD50 1375 mg/kg bw) and the type of use
intake by birds and mammals of the active substance via water is considered as negligible. Although
PEC/PNEC ratios could not be calculated, it can be concluded that no risk for secondary poisoning
has been identified based on the low BCF value, see section 2.8.3.5.
2.8.4.5 PBT assessment
PBT assessment is summarized in the N,N-diethyl-m-toluamide (DEET) CAR, Doc I section 2.2.2.3.
PBT assessment. DEET does not meet any of the criteria for Persistent, Bioaccumulative and Toxic
(PBT) substances or the very Persistent, very Bioaccumulative (vPvB) category.
Conclusion
Summary table for the risk assessment of this product.
PEC/PNECstp PEC/PNECwater PEC/PNECsed PEC/PNECsoil PEC/PNECGW
Scenario 1,
Indirect
release Unacceptable Unaceptable
Scenario 2,
Direct
release Acceptable Unaceptable Unaceptable Unaceptable Unacceptable
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
Unacceptable risk has been found for surface water and sediment for both direct and indirect
emission scenarios, for indirect emission also unacceptable risk has been found for soil and
groundwater.
However, ESCA considers that the product should be authorized despite unacceptable risk for the
environmental compartments since there is not many insect repellent products containing active
substances with different modes of action available for this use. Hence the unauthorisation of the
product GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY would have
disproportionate negative consequences for the society against the risk for the environment.
We consider that the product should be authorized, despite unacceptable risk to the environment, in
application of article 19(5) of the Biocidal product Regulation 528/2012.
The following risk mitigation measures must be followed when using the product, notably to limit
risk for the consumers and the environment:
- The biocidal product is to be applied only once a day
- Use one wipe for application.
- Apply the product sparingly and carefully to parts of the body that are not covered. Do not apply
on clothes; divide the product evenly over the skin
- Empty containers, unused product and wipes are considered hazardous waste. Dispose of in
accordance with current regulations.
- Do not release to soil, ground, surface water or any kind of sewer
2.9 Measures to protect man, animals and the environment
The instructions for use must contain the following indications:
Apply only on the uncovered skin (head, arms and hands). Long trousers and long-sleeved
shirt should be worn. Do not apply on clothing.
Apply the product sparingly and carefully; divide the product evenly over the skin.
The biocidal product is to be applied only once a day.
In addition, other indications must be considered:
For the product GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY, unacceptable
risks were identified for the environment but the following risk mitigation measures are required:
- The biocidal product is to be applied only once a day
- Apply the product sparingly and carefully to parts of the body that are not covered. Do not apply
on clothes; divide the product evenly over the skin
- Empty containers, unused product IS considered hazardous waste. Dispose of in accordance with
current regulations.
- Do not release to soil, ground, surface water or any kind of sewer
Regarding the possibility of destruction or decontamination following release in or on the
following: (a) Air, (b) Water, including drinking water, and (c) Soil:
a) The risk of release of the active ingredient or the product to atmosphere is negligible.
b) Leak/spill: Remove all sources of ignition. Use an inert absorbent material, and non-
sparking tools. Ventilate area. Prevent from entering a watercourse.
Because of the smell and taste of DEET, it acts as a self deterrent against consumption by humans
and animals. The GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY product
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
contains an ingredient that acts as a strong deterrent for ingestion (denatonium benzoate). For the
product GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY, risks were identified for
the human health taking into account the following risk mitigation measures are required:
Do not apply on clothing.
Apply the product sparingly and carefully; divide the product evenly over the skin.
The application for adults and children over 2 years of age must be restricted to one application a
day. Children under 2 years must not be treated with this product.
The biocidal product is not for use on children under 2 years of age.
Avoid contact with eyes, mucous membranes, nose, lips and damaged skin. Apply carefully to areas
where skin folds normally occur.
Do not apply on young children´s hands. For other users, wash your hands thoroughly with soap and
water before eating or drinking.
Do not mix with other chemical substances/mixtures.
When used in combination with sun block lotion, apply sun block first then wait 30 minutes before
applying the biocidal product.
Wash the areas of skin that have been treated when protection is no longer needed or if side effects
occur.
The biocidal product must not be applied where food, feeding stuffs or drinking water can become
contaminated.
Apply hygiene measures: do not eat, drink or smoke during the applying of the product and wash
hands after use.
Use only outdoors or in a well-ventilated area.
Do not inhale the product.
Keep this product away from children.
Avoid contact with plastics, synthetic-/leather clothing and painted surfaces.
Specific treatment in case of an accident, e.g. first aid measures, antidotes, medical treatment
if available.
Poisoning may cause:
- Irritation of the eyes, skin, mucous membranes, respiratory and gastrointestinal tract.
- Allergic skin reaction (including anaphylaxis).
- Overuse and/or multiples dermal applications may cause neuronal disorders (behavioural
disorders, ataxia, hypertonia, seizures, encephalopathy and coma).
Basic first aid procedures
- Move the person away from the contaminated area and remove contaminated or spattered
clothing
- If contact in eyes, rinse with plenty of water for 15 minutes. Do NOT forget to remove the
contact lenses.
- If contact on skin, wash with soap and plenty of water, without rubbing. Remove the product
from skin folds and from under fingernails.
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
- If swallowed, do NOT induce vomiting unless told to do so by poison control or a health
care professional. Call immediately to a poison control center and if necessary take the
person to a hospital and show the label or packaging whenever possible.
- Keep the patient at rest and maintain the body temperature.
- If the person in unconscious, turn the patient sideways with the head at lower than the rest of
the body and the knees bended.
- If necessary take the person to a hospital and show the label or packaging whenever
possible.
DO NOT LEAVE THE POISENED PERSON ALONE UNDER ANY CIRCUMSTANCE
Medical advice for doctors and sanitary staff
- Gastrointestinal decontamination is not recommended.
- Contraindication: Syrup of Ipecac
- Symptomatic and supportive treatment.
IF MEDICAL ADVICE IS NEEDED, HAVE THE PRODUCT CONTAINER OR LABEL AT
HAND AND CONTACT THE POISON CONTROL CENTER.
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
3 Proposal for decision
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY is a spray (ready-to-use) for non-
professional / general public use for the purpose of spraying on the body areas to be protected that
contains 45% (w/w) DEET (N, N-diethyl-meta-toluamide).
The physico-chemical properties have been evaluated and there are no hazards associated with the
product under normal conditions of use.
These tests show the efficacy of GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
against mosquitoes in simulated-use tests (arm-in-cage) and against ticks in a laboratory test. The
results of the arm-in-cage studies show that GOIBI XTREME FORTE REPELENTE DE
INSECTOS SPRAY repels Anopheles spp. and Aedes spp. for on average 5 and 8 hours respectively.
The laboratory test with Ixodes ricinus shows that ticks are repelled for at least 8 hours.
Regarding the risk for human health of non-professional users it can be concluded that there is risk
for each subpopulation (adults, children younger than 12 years old, and children older than 12 years
old: the product can be used once per day on adults and children over 2 years. Children’s hands must
not be treated with this product. Children under 2 years must not be treated with this product. For
reasons of public health, GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY must be
authorized on the grounds of Article 19(5) of Regulation (EU) No 528/2012 of the European
Parliament and of the Council of 22 May 2019 concerning the market and use of biocidal product.
The environmental risk associated with the use of GOIBI XTREME FORTE REPELENTE DE
INSECTOS SPRAY has been evaluated when applied directly on uncovered human skin. The
product, containing 45 % (450 g/kg) DEET will be used to protect against mosquito bites, tiger
mosquitoes, ticks and other arthropods (flies and horseflies). The product belongs to the scenario
category PT19 Repellents and attractants). It is directly applied on the skin 1 time per day and is
used by non-professional users.
The overall conclusion is that the intended use of GOIBI XTREME FORTE REPELENTE DE
INSECTOS SPRAY poses risks to the environment when is direct released to surface water and
sediment via swimming and indirect risk on surface water, sediment, soil and groundwater.
However, we consider that the product should be authorized, despite unacceptable risk to the
environment, in application of article 19(5) of the Biocidal product Regulation 528/2012.
The following risk mitigation measures must be followed when using the product, notably to limit
risk for the consumers and the environment- The biocidal product is to be applied only once a day:
- Apply the product sparingly and carefully to parts of the body that are not covered. Do not apply
on clothes; divide the product evenly over the skin
- Empty containers, unused product is considered hazardous waste. Dispose of in accordance with
current regulations.
- Do not release to soil, ground, surface water or any kind of sewer
The Spanish CA authorises under certain conditions of use the biocidal product GOIBI
XTREME FORTE REPELENTE DE INSECTOS SPRAY as a repellent (PT19) for dermal
use, against mosquito, tiger mosquito, ticks by spraying on the body areas to be protected by
non-professional users.
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
Particular Conditions
The biocidal product under PT19 (Repellent) GOIBI XTREME FORTE REPELENTE DE
INSECTOS SPRAY contains 45% (w/w) DEET (N, N-diethyl-meta-toluamide).
The active substances as manufactured shall have the following minimum purities:
DEET (N, N-diethyl-meta-toluamide): 970 g/kg
Only ready-to-use GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY product is
authorised.
Read attached instructions before use.
The biocidal product acts against vector-borne topical diseases as for example malaria, yellow fever,
zika virus, dengue fever or chikungunya.
The product is authorised only for use against Anopheles spp. and Aedes spp. for on average 5 and 8
hours respectively. The laboratory test with Ixodes ricinus shows that ticks are repelled for at least 8
hours. Authorisation of this product does not allow use against non-target organisms.
Apply only in areas where there is significant risk of infection by vector-borne diseases.
Apply GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY only on the uncovered skin
(head, arms and hands). Long trousers and long-sleeved shirt should be worn. Do not apply on
clothing.
Apply the product sparingly and carefully; divide the product evenly over the skin.
The application for adults and children over 2 years of age must be restricted to one application a
day.
The biocidal product is not for use on children under 2 years of age.
Apply the product sparingly and carefully to parts of the body that are not covered by clothing;
divide the product evenly over the skin.
Keep the spray bottle at least 15 cm from the skin; do not spray directly on the face. To protect the
face from insect bites, first spray or spread a small quantity of the product onto the palm of the hand
and then spread on the face.
Avoid contact with eyes, mucous membranes, nose, lips and damaged skin. Apply carefully to areas
where skin folds normally occur.
Do not apply on young children´s hands. For other users, wash your hands thoroughly with soap and
water before eating or drinking.
The product contains an aversive or bittering agent.
Do not mix with other chemical substances/mixtures.
When used in combination with sun block lotion, apply sun block first then wait 30 minutes before
applying the biocidal product.
Wash the areas of skin that have been treated when protection is no longer needed or if side effects
occur.
The product must not be applied where food, feeding stuffs or drinking water can become
contaminated.
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
Apply hygiene measures: do not eat, drink or smoke during the applying of the product and wash
hands after use.
Use only outdoors or in a well-ventilated area.
Do not inhale the product.
Keep this product away from children.
Avoid contact with plastics, synthetic-/leather clothing and painted surfaces.
The packaging of the biocidal product shall be fitted with a tactile warning of danger.
The packaging of the product placed on the market has to be limited to a maximum size of 200ml.
Do not throw the product on the ground, into a water course, into the sink or down the drain.
Dispose of contents/container as a hazardous waste at household waste recycling centres.
Expiry Date of the Authorisation:
The authorisation of the product GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
expires on 31 July 2022, which is the expiry date of Annex I listing of the active substance DEET
(N, N-diethyl-meta-toluamide).
Nevertheless, the authorisation of the biocidal product GOIBI XTREME FORTE REPELENTE DE
INSECTOS SPRAY is conditioned to the submission a storage stability long term study at ambient
temperature (2 years) in June 2018.
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
Annex:
1. Summary of product characteristics
2. List of studies reviewed
3. Analytical methods residues – active substance
4. Toxicology and metabolism –active substance
5. Toxicology – biocidal product
6. Safety for professional operators
7. Safety for non-professional operators and the general public
8. Residue behaviour
SECRETARIA GENERAL DE
SANIDAD Y CONSUMO
DIRECCIÓN GENERAL DE
SALUD PÚBLICA, CALIDAD
E INNOVACIÓN
MINISTERIO
DE SANIDAD, CONSUMO
Y BIENESTAR SOCIAL
Summary of product characteristics for a biocidal product
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
Product type(s) [19]
ES/APP(NA)-2016-19-00365
ES-0008618-0000
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
2
1. Administrative information
1.1. Trade name(s) of the product
Trade name(s)4 GOIBI XTREME FORTE REPELENTE DE
INSECTOS SPRAY
1.2. Authorisation holder
Name and address of the
authorisation holder
Name Laboratorios Cinfa, S.A.
Address Olaz-Chipi, nº 10
31620 - Huarte (Pamplona)
Authorisation number ES/APP(NA)-2016-19-00365
Suffixes to the authorisation number
linked to trade names5
R4BP asset reference number ES-0008618-0000
Date of the authorisation 19/05/2019
Expiry date of the authorisation 31 July 2022
1.3. Manufacturer(s) of the product
Name of manufacturer 1 Laboratorios Cosméticos Feltor, S.A. (bulk product
manufacture)
Address of manufacturer Pol. Ind. "Molí de les Planes"
C/ Roques Blanques, 3-5
08470 San Celoni (Barcelona)
Spain
Location of manufacturing sites Pol. Ind. "Molí de les Planes"
C/ Roques Blanques, 3-5
08470 San Celoni (Barcelona)
Spain
1.4. Manufacturer(s) of the active substance(s)
Active substance DEET (N,N-diethyl-m-toluamide)
Name of manufacturer Vertellus Performance Materials Inc. (formerly Morflex,
Inc.)
Address of manufacturer Vertellus Performance Materials Inc.
2110 High Point Road
Greensboro (NC)
NC 27403 (USA)
Location of manufacturing sites Vertellus Performance Materials Inc.
2110 High Point Road
Greensboro (NC)
NC 27403 (USA)
4 In case the product would have more than one name, all names can be provided in this field.
5 Where relevant for the Member State delivering a national authorisation. Insert rows as necessary.
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
3
2. Product composition and formulation
2.1. Qualitative and quantitative information on the composition of the product
Common
name
IUPAC name Function
CAS
number
EC
number
Content
(%)
DEET N, N-diethyl-m-
toluamide
Active
substance 134-62-3 205-149-7 45
Ethanol Solvent 64-17-5 200-578-6 49.9995
Non active
substance
2.2. Type of formulation
Spray
3. Hazard and precautionary statements6
Hazard statements H225: Highly flammable liquid and vapour
H319: Causes serious eye irritation
EUH 208: “Contains D- limonene and Citral. May produce an
allergic reaction”
H412: Harmful to aquatic life with long lasting effects.
Precautionary
statements
P102: Keep out of reach of children
P103: Read label before use
P210: Keep away from heat/sparks/open flames/hot surfaces. No
smoking
P233: Keep container tightly closed
P264: Wash … thoroughly after handling
P273: Avoid release to the environment
P370+P378: In case of fire: use....for extinction
P403+P235: Store in a well-ventilated place. Keep cool
P501: Dispose of contents/containers to hazardous waste facilities
in accordance with national regulations
P501: Dispose of content and / or its container as hazardous waste
according to the regulations in force.
4. Authorised use(s)
4.1. Use description7
6 According to Regulation (EC) 1272/2008, or where relevant, Directive 1999/45/EC. This section shall only include precautionary
statements triggered by the CLP legislation. In accordance with paragraph 8 of document CA-May13-Doc.5.4, a precautionary statement that
has been proven unnecessary in the risk assessment because of the intended use of the product should be left out of the SPC and of the label. For micro-organisms based products: indication on the need for the biocidal product to carry the biohazard sign specified in Annex II to
Directive 2000/54/EC (Biological Agents at Work). 7 Copy this section as many times as necessary (one table per use, together with any instructions for use, risk mitigation measures and other
directions for use that are use-specific. It has to be noted that in accordance with Document CA-May14-Doc.5.6 – Final, the SPC of a single
biocidal product presents the authorised uses as a number of pre-defined uses to which the product label shall have full correspondence.
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
4
Table 1. Use # 1 – Repellent – Mosquitoes and ticks– Non-professional user (general public) – Adults
and children > 2 years - Spray – Indoor and Outdoor use
Product Type PT19, repellent
Where relevant, an exact
description of the
authorised use
Repellent against mosquitoes and ticks for human hygiene
Target organism(s)
(including development
stage)
Mosquitoes: Aedes albopictus and Anopheles gambiae
Ticks: Ixodes ricinus
Field(s) of use Outdoor and indoor and use in a well-ventilated area
Application method(s) Topical application in human skin by spray
Application rate(s) and
frequency
The product is to be applied only once a day for adults and children
over 2 years of age.
The maximum time protection is between 5 and 8 hours for
mosquitoes and until 8 hours for ticks.
Category(ies) of users Non professional user (general public)
Pack sizes and packaging
material
The biocidal product is packaged in a PP container of 75 ml with
cap dispensers of 0.14 ml.
4.1.1. Use-specific instructions for use8
See section 5.1
4.1.2 Use-specific risk mitigation measures
See section 5.2
4.1.3 Where specific to the use, the particulars of likely direct or indirect effects, first aid
instructions and emergency measures to protect the environment
See section 5.3
4.1.4 Where specific to the use, the instructions for safe disposal of the product and its
packaging
See section 5.4
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under
normal conditions of storage
See section 5.5
8 Describe the necessary instructions for use like for example: period of time needed for the biocidal effect; the interval to be observed
between applications of the biocidal product or between application and the next use of the product treated, or the next access by humans or
animals to the area where the biocidal product has been used, including particulars concerning decontamination means and measures and duration of necessary ventilation of treated areas; particulars for adequate cleaning of equipment; particulars concerning precautionary
measures during transport; precautions to be taken to avoid the development of resistance.
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
5
5. General directions for use9
5.1. Instructions for use6
Read attached instructions before use.
The biocidal product acts against vector-borne topical diseases as for example malaria, yellow
fever, zika virus, dengue fever or chikungunya.
Apply only on the uncovered skin Do not apply on clothing.
Apply the product sparingly and carefully; divide the product evenly over the skin.
Keep the spray bottle at least 15 cm from the skin; do not spray directly on the face. To protect the
face from insect bites, first spray or spread a small quantity of the product onto the palm of the
hand and then spread on the face.
The application for adults and children over 2 years of age must be restricted to one application a
day.
Children under 2 years of age must not be treated with this product.
The biocidal product is not for use on children under 2 years of age.
5.2. Risk mitigation measures
Apply in areas where there is significant risk of infection by vector-borne diseases.
Avoid contact with eyes, mucous membranes, nose, lips and damaged skin. Apply carefully to
areas where skin folds normally occur.
Do not apply on young children´s hands. For other users, wash your hands thoroughly with soap
and water before eating or drinking.
The product contains an aversive or bittering agent.
Do not mix with other chemical substances/mixtures.
When used in combination with sun block lotion, apply sun block first then wait 30 minutes before
applying the biocidal product.
Wash the areas of skin that have been treated when protection is no longer needed or if side effects
occur.
The biocidal product must not be applied where food, feeding stuffs or drinking water can become
contaminated.
Apply hygiene measures: do not eat, drink or smoke during the applying of the product and wash
hands after use.
Use only outdoors or in a well-ventilated area.
9 Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses.
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
6
Do not inhale the product.
Keep this product away from children.
Avoid contact with plastics, synthetic-/leather clothing and painted surfaces.
The packaging of the product placed on the market has to be limited to a maximum size of 200ml.
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency
measures to protect the environment
Poisoning may cause:
- Irritation of the eyes, skin, mucous membranes, respiratory and gastrointestinal tract.
- Allergic skin reaction (including anaphylaxis).
- Overuse and/or multiples dermal applications may cause neuronal disorders (behavioural
disorders, ataxia, hypertonia, seizures, encephalopathy and coma).
Basic first aid procedures
- Move the person away from the contaminated area and remove contaminated or spattered
clothing
- If contact in eyes, rinse with plenty of water for 15 minutes. Do NOT forget to remove the
contact lenses.
- If contact on skin, wash with soap and plenty of water, without rubbing. Remove the product
from skin folds and from under fingernails.
- If swallowed, do NOT induce vomiting unless told to do so by poison control or a health care
professional. Call immediately to a poison control center and if necessary take the person to a
hospital and show the label or packaging whenever possible.
- Keep the patient at rest and maintain the body temperature.
- If the person in unconscious, turn the patient sideways with the head at lower than the rest of
the body and the knees bended.
- If necessary take the person to a hospital and show the label or packaging whenever possible.
DO NOT LEAVE THE POISENED PERSON ALONE UNDER ANY CIRCUMSTANCE
Medical advice for doctors and sanitary staff
- Gastrointestinal decontamination is not recommended.
- Contraindication: Syrup of Ipecac
- Symptomatic and supportive treatment.
IF MEDICAL ADVICE IS NEEDED, HAVE THE PRODUCT CONTAINER OR LABEL AT
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
7
HAND AND CONTACT THE POISON CONTROL CENTER.
5.4. Instructions for safe disposal of the product and its packaging
Dispose of content and / or its container as hazardous waste according to the regulations in force.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
The product is stable for 3 months.
6. Other information
The packaging of the biocidal product shall be fitted with a tactile warning of danger.
Definition of non-professional users (general public): users who are not professionals and that
apply the biocidal product is in his private life.
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
8
Annex 2: List of studies reviewed
List of new data10
submitted in support of the evaluation of the active substance
Section
No
Reference
No
Author Year Title
Owner of data Letter of Access Data
protection
claimed
Yes No Yes No
Add rows as necessary
List of new data submitted in support of the evaluation of the biocidal product
Section
No
Reference
No
Author Year Title Owner of data Letter of Access Data
protection
claimed
Yes No Yes No
B 3.4 and
B 3.10
201303527 Nicola Mazzei 2013 Determination of the
Physicochemical properties on
the sample Goibi Xtrem
Antimosquitos Tropical Loción
Laboratoris Feltor, S.A X X
B3.5 F6002.-G006 Laura del Aro 2014 Determinación pH y
Acidez/Alcalinidad en el
producto Goibi Antimosquitos
Xtrem Spray
Laboratorios Feltor, S.A. X X
B3.6 F6002.-G006 Laura del Aro 2014 Determinación densidad en el
producto Goibi Antimosquitos
Xtrem Spray
Laboratorios Feltor, S.A. X X
10 Data which have not been already submitted for the purpose of the Annex I inclusion.
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
9
Section
No
Reference
No
Author Year Title Owner of data Letter of Access Data
protection
claimed
B 3.7 EET
5030/06-1
Ane de la Maza
Uriarte
2006 Protocolo de Estudio de
Estabilidad según ICH Q1A del
producto Loción Repelente de
Insectos Tropical
Laboratorios Cinfa, S.A. X X
B 3.7 F6176.-E001-
E002-E003
Gemma Rodergas 2012 Estudio de Estabilidad del
producto Líquido Goibi
Antimosquitos Xtreme Spray en
3 meses
Laboratorios Feltor, S.A. X X
B 4 Ref.51 UDA Ane de la Maza 2007 Informe de Validación del
Método de determinación de
N,N-Dietil-m-Toluamida en
materia prima
Laboratorios Cinfa, S.A. X X
B 4 Ref.52 UDA Ane de la Maza 2006 Informe de Validación del
Método de valoración de N,N-
Dietil-m-Toluamida en Repelente
de Insectos Tropical
Laboratorios Cinfa, S.A. X X
B6.2(1) CD06/10095
T
Silvia López 2006 Test de irritación dérmica
primaria en conejos. Producto
ensayado GOIBI
ANTIMOSQUITOS XTREME
SPRAY
Laboratorios Cinfa, S.A. X X
B6.2(2) CD06/10096
T
Silvia López 2006 Test de tolerancia cutánea a las
aplicaciones repetidas durante
dos semanas, en conejo
Laboratorios Cinfa, S.A. X X
B6.3 134814 Katharina
Weidmann
2013 Test for sensitisation (Local
Lymph Node Assay – LLNA)
with GOIBI ANTIMOSQUITOS
XTREME SPRAY
Laboratorios Cinfa, S.A. X X
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
10
Section
No
Reference
No
Author Year Title Owner of data Letter of Access Data
protection
claimed
B6.4 134813 Dipl.-Ing. (FH)
Kristin Rödig
2014 Percutaneous Absorption of
GOIBI ANTIMOSQUITOS
XTREME SPRAY – in vitro
method
Laboratorios Cinfa, S.A. X X
Add rows as necessary
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
11
Annex 3: Analytical methods residues – active substance
DEET
Matrix, action levels, relevant residue and reference
matrix limit relevant residue reference or comment
plant products Not required as the use
pattern of DEET will not
results in any contact with
food or feeding stuffs
food of animal
origin
Not required as the use
pattern of DEET will not
results in any contact with
food or feeding stuffs
soil LOQ 0.01 mg/Kg LC-MS/MS
water LOQ: 1.0 ng/L
LOD:0.02 ng/mL
(equivalent to
0.2 ng/L in
water)
The UPLC-MS/MS method
in ground and drinking
water was demonstrated to
be accurate, precise,
sensitive and specific.
surface water LOQ: 0.1 g/L UPLC-MS/MS
air No method considered
required based on the use
pattern and properties of
DEET
body fluids /
tissues
LOQ 49.4μg/L In blood plasma HPLC-UV. No
confirmatory method
provided. No further data
required as DEET is not
classified as toxic or highly
toxic.
Methods suitable for the determination of residues (monitoring methods)
Methods for products of plant origin
reference matrix LOQ
(mg/kg)
principle comment owner
Not necessary,
since the
contemplated use
of DEET does
not involve
contact with food
or feed
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
12
Methods for foodstuffs of animal origin
reference matrix LOQ
(mg/kg)
principle comment owner
Not necessary,
since the
contemplated use
of DEET does
not involve
contact with food
or feed
Methods for soil
reference LOQ
(mg/kg)
principle comment owner
0.01 LC-MS/MS DEET -
EUJV
Methods for drinking water and surface water
reference matrix LOQ
(µg/l)
principle comment owner
Drinking and
ground water
Surface water
1.0
ng/L
0.1µg/L
UPLC-MS/MS DEET -
EUJV
Methods for air
reference LOQ
(µg/m3)
principle comment owner
No method has
been considered
necessary, based
on the
contemplated use
and properties of
DEET, and the
representative
product.
Methods for body fluids/tissue
reference matrix LOQ
(mg/kg)
principle comment owner
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
13
reference matrix LOQ
(mg/kg)
principle comment owner
Blood plasma 49.4μg/L HPLC-UV No further data
Required as
DEET is not
classified as toxic
or highly toxic
DEET -
EUJV
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
14
Annex 4: Toxicology and metabolism –active substance
DEET
This information can be consulted in the Assessment Reports of the active substance DEET
(N,N-diethyl-m-toluamide)
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
15
Annex 5: Toxicology – biocidal product
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
General information Formulation Type Spray (ready to use)
Active substance(s) (incl. content) 45% DEET
Category
Acute toxicity, irritancy and skin sensitisation of the preparation (Annex IIIB, point 6.1, 6.2,
6.3)
Rat LD50 oral (OECD 420) Justification for non submission of data*
Rat LD50 dermal (OECD 402) Justification for non submission of data*
Rat LC50 inhalation (OECD 403) Justification for non submission of data*
Skin irritation (OECD 404) No irritant
Eye irritation (OECD 405) Justification for non submission of data*
Skin sensitisation (OECD 429; LLNA) No sensitiser
*No study was submitted about acute toxicity. Justification for non-submission of data has been
submitted for acute oral, dermal and inhalation toxicity. The Spanish CA accepts the applicant's
justification and the data package.
The active substance DEET is classified as dangerous substances by oral acute toxicity and it exists in
concentration that contributes to the classification of the product. On the other hand, according to CLP
Regulation, where the mixture itself has not been tested to determine its acute toxicity, but there are
sufficient data on the individual ingredients and similar tested mixtures to adequately characterise the
hazards of the mixture, these data shall be used in accordance with the bridging rules. The acute
toxicity estimate (ATE) of the mixture is determined by calculation from the ATE values for all
relevant ingredients according to the following formula for oral, dermal or inhalation toxicity:
where:
Ci = concentration of ingredient i (% w/w or % v/v)
i = the individual ingredient from 1 to n
n = the number of ingredients
ATEi = Acute Toxicity Estimate of ingredient i
Considering the LD50 (oral) value and concentration of DEET, the ATEmix is 4166 mg/kg and the
biocidal product is not classified by oral acute toxicity according to CLP Regulation, table 3.1.1.
In addition, the biocidal product GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
does not contain any dangerous substance classified by dermal and inhalation acute toxicity. The study
of acute inhalation toxicity was waived because the inhalation route is excluded due to the use
outdoor, and because the use indoor only takes place in summer, in situations where there is a high
ventilation rate. Furthermore, as reported in the CAR of DEET, the active substance is a low volatile
compound that has not and high distribution in air compartment.
No study was submitted about eye irritation. The active substance DEET was classified in the CAR as
irritant to eyes according to Directive 1999/45/EC and according to CLP Regulation, Annex VI.
Considering the concentration of the active substance, the biocidal product GOIBI XTREME FORTE
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
16
REPELENTE DE INSECTOS SPRAY is classified as Eye irrit. 2 and the hazard statement according
to CLP Regulation (the concentration is higher than 10%).
A study was conducted to assess the skin sensitization potential with the biocidal product in mice. The
method was carried out according to the guidelines of OECD N° 429 (skin sensitisation: Local lymph
node assay, LLNA method). The purpose of this local lymph node assay was to identify the contact
allergenic potential of GOIBI ANTIMOSQUITOS XTREME SPRAY when administered to the
dorsum of both ear lobes of mice at concentrations of 25%, 50% (each diluted with acetone/olive oil
4:1 v/v) and 100%. On basis of the results, at the daily clinical observation the animals did not show
any visible clinical symptoms and no case of mortality was observed. None of the three tested
concentrations of the test item reached the simulation index of 3.
- The stimulation index at a concentration of 25% was 1.2.
- The stimulation index at a concentration of 25% was 2.0.
- The stimulation index at a concentration of 25% was 1.4.
Consequently, according to OECD 429 the biocidal product GOIBI XTREME FORTE REPELENTE
DE INSECTOS SPRAY is expected to have no sensitising properties and therefore should not be
regarded as a dermal sensitiser.
Nevertheless, some substances included in the biocidal product could produce an allergic reaction.
These substances (fragrances) are not present in the biocidal product at sufficient concentration(s) to
trigger a human health classification but, according to the Regulation 286/2011 of 10 March 2011
amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No
1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of
substances and mixtures (section 2.8, Annex II), the label on the packaging of mixtures not classified
as sensitising but containing at least one substance classified as sensitising and present in a
concentration equal to or greater than that specified in Table 3.4.6 of Annex I, of this regulation, shall
bear the statement:
EUH208 — “Contains (name of sensitising substance). May produce an allergic reaction”.
For this reason, the label of GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY will
include the statement: EUH 208: “Contains D- Limonene and Citral. May produce an allergic
reaction” according to CLP Regulation.
Additional toxicological information (e.g. Annex IIIB, point 6.5, 6.7) Short-term toxicity studies
Toxicological data on active substance(s)
(not tested with the preparation)
Toxicological data on non-active substance(s)
(not tested with the preparation)
Further toxicological information
Classification and labelling proposed for the preparation with regard to toxicological properties
(Annex IIIB, point 9) Regulation 1272/2008/EC Eye irrit. 2
H319: Causes serious eye irritation
EUH208: Contains D- Limonene and Citral. May produce an allergic
reaction
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
17
Annex 6: Safety for professional operators
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
Exposure assessment
Exposure scenarios for intended uses (Annex IIIB, point 6.6 )
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY is not intended for professonal use.
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
18
Annex 7: Safety for non-professional operators and the general public
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
General information Formulation Type Spray (ready to use)
Active substance(s) (incl. content) 45% DEET
Category
Authorisation number ES/APP(NA)-2016-19-00365
DEET (N,N-diethyl-m-toluamide)
Data base for exposure estimation according to Appendix: Toxicology and metabolism – active substance/CAR and UK
Proforma (reverse scenario)
Exposure scenarios for intended uses (Annex IIIB, point 6.6 ) Conclusion:
Regarding the risk for human health of non-professional users it can be concluded that there is risk for
each subpopulation (adults, children < 12 years old, and children > 12 years old): the product can be
used once per day on adults and children > 2 years. Children’s hands must not be treated with this
product. Children under 2 years must not be treated with this product.
For reasons of public health, GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY must
be authorized on the grounds of Article 19(5) of Regulation (EU) No 528/2012 of the European
Parliament and of the Council of 22 May 2019 concerning the market and use of biocidal product.
Details for the exposure estimates:
Internal dermal dose a.s. = (Number of applications) × External dermal dose product × (content a.s.) ×
(% dermal absorption)
Internal oral dose a.s. = (Number of applications) × External oral dose product × (content a.s.) × (%
ingested amount)
Total dose a.s.= Internal dermal dose a.s + Internal oral dose a.s
External dose (x mg/kg/d product) = AELrepeated / Internal dose (x mg/kg/d a.s.)
Number of sprays = External dose (x mg/kg/d product) /Amount of spray in a single spray spot (mg)
Area of skin (limit dose) = External dose (x mg/kg/d product) / Efficacy
Number of applications = Area of skin (limit dose)/Area could be treated.
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
19
Scenario Adult /
Children > 12
Children 6
to < 12
Children 2
to < 6
potential Dermal (applied)
nº application/day 1 1 1
Concentration DEET (% w/w) 45 45 45
AELdermal (mg a.s./kg bw/day) = Application rate
"saferty" 8,2 8,2 8,2
Body weight (kg) 60 23,9 15,6
Dermal absorption (%) 11 11 11
Oral absorption (%) 100 100 100
Dermal (0,96 mg product/Kg/day) / (1 mg
product/Kg/day) 0,96 0,92 0,92
Oral (0,04 mg product/Kg/day) / (1 mg
product/Kg/day) 0,04 0,08 0,08
Amount of a.s. (mg) per mg product (Dermal) = (mg
a.s/Kg/day) / (mg product/Kg/day) INTERNAL DOSE
A.S
0,0475 0,0455 0,0455
Amount of a.s. (mg) per mg product (Oral) = (mg
a.s/Kg/day) / (mg product/Kg/day) INTERNAL DOSE
A.S
0,0180 0,0360 0,0360
Amount of a.s. (mg) per mg product (dermal + oral) =
(mg a.s/Kg/day) / (mg product/Kg/day) TOTAL DOSE
A.S.
0,0655 0,0815 0,0815
Amount of PRODUCT applied to reach repeated AEL
(mg product /Kg/day) 125 101 101
Amount of PRODUCT applied to reach repeated AEL
(mg product /day) 7509 2403 1569
Amount of spray in a single spray spot (mg) 140 140 140
Number of sprays 54 17 11
Eficacy (1,15 g/600 cm2) 0,0019 0,0019 0,0019
Area of skin that can be treated with product in one day
[cm2] 3918 1254 819
Body surface (cm2) 16660 9200 6800
Number of applications 0,2 0,1 0,1
% skin that can be treated 24 14 12
GOIBI XTREME FORTE REPELENTE DE INSECTOS SPRAY
20
Annex 8: Residue behaviour
DEET
Intended Use (critical application)
Active substance(s):45% DEET
Formulation of biocidal product: spray (ready to use)
Place of treatment: Apply the spray on the body areas to be protected
The intended use descriptions of the DEET containing biocidal products for which authorisation is
sought indicate that these uses are not relevant in terms of residues in food and feed. No further data
are required concerning the residue behaviour.
The acute or chronic exposure to residues in food resulting from the intended uses is unlikely
to cause a risk to consumers. Regarding consumer health protection, there are no objections
against the intended uses.